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Adverse Event Report

DEPUY SPINE, INC. SCREWS - TYPE UNK INTERNAL FIXATION   back to search results
Event Date 01/01/1993
Event Type  Injury  
Event Description

Patient reports that he underwent surgery, in dec. 1992, involving implant of screws right and left sides for pain, disk rupture #4, 5 and 6 also fusion with bone chips. Patient reports pain from and removal of portion of implants in jan. 1993. Patient reports that he may need additional surgery.

 
Manufacturer Narrative

Is frequency of occurrence of this event addressed in the device labeling? yes. If yes, then is frequency of this event greater than labeled? no. Is severity of this event addressed in the device labeling? yes. If yes, then is the severity of this event greater than labeled? no a report or other information submitted by a reporting entry under this part, and any release by fda of that report of information, does not necessarily reflect a conclusion by the part submitting the report or by fda thae the report or information constitutes an admission that the device, or the reporting entry or its employees or agents, caused or contributing to the reportable event. The reporting entry need not admit and may deny (and expressly reserves the right to deny) that the device, the party submitting the report, or employees thereof caused or contributed to a reportable event.

 
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Brand NameSCREWS - TYPE UNK
Type of DeviceINTERNAL FIXATION
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section G)
DEPUY SPINE, INC.
325 paramount dr.
raynham MA 02767
Device Event Key77386
MDR Report Key89515
Event Key73184
Report Number1526439-1997-00018
Device Sequence Number1
Product CodeJDN
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/09/1997
Is This An Adverse Event Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Date Manufacturer Received04/09/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on December 31, 2008

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