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Adverse Event Report

W.L. GORE & ASSOCIATES, INC. GORE-TEX REGENERATIVE MEMBRANE TRANSGINGIVAL REGENERATION MATERIAL   back to search results
Model Number 502
Event Date 11/22/2006
Event Type  Injury  
Manufacturer Narrative

No lot number information has been supplied, therefore, a review of the manufacturing paperwork can not be conducted. No device was returned for examination. Note: the device was not returned. Consequently, a direct product analysis was not possible. We have no reason to believe that the device performed other than expected. Without additional information, it is impossible to further investigate this event.

 
Event Description

It was reported that the patient had been treated with a gore-tex regenerative membrane in 2003. It is unclear regarding the chronology of events; however, at some time later, the patient developed a systemic infection and returned to the hospital. It is unclear if the return to the hospital is related or unrelated to the gore device. Additionally, it was reported that the device migrated from the #2 position in the mouth to the #4 position. Reportedly, this was confirmed by an independent second periodontist using x-ray. The limited information regarding this event has been provided to gore by the implanting periodontist. Any further information related to this event will be provided by the implanting periodontist's legal counsel. Based on the information provided, it is unknown the exact chronology of events, accuracy of information, or patient status related to this event.

 
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Brand NameGORE-TEX REGENERATIVE MEMBRANE
Type of DeviceTRANSGINGIVAL REGENERATION MATERIAL
Baseline Brand NameGORE-TEX REGENERATIVE MEMBRANE
Baseline Generic NameTRANSGINGIVAL REGENERATION MATERIAL
Baseline Catalogue NumberUNK
Baseline Model Number502
Other Baseline ID NumberUNK
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
W.L. GORE & ASSOCIATES, INC.
3750 west kiltie lane
flagstaff AZ 86001
Manufacturer (Section D)
W.L. GORE & ASSOCIATES, INC.
3750 west kiltie lane
flagstaff AZ 86001
Manufacturer (Section G)
W. L. GORE & ASSOCIATES, INC.
3750 west kiltie lane
flagstaff AZ 86001
Manufacturer Contact
craig bearchell
3450 west kiltie lane
flagstaff , AZ 86004
(928) 526 -3030
Device Event Key786455
MDR Report Key798937
Event Key762613
Report Number2017233-2006-00377
Device Sequence Number1
Product CodeLYC
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/21/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2006
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number502
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/22/2006
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on January 30, 2009

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