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Adverse Event Report

3M UNITEK CORP. BONDABLE LINGUAL CLEAT ORTHODONTIC, ATTACHMENT, LINGUAL   back to search results
Catalog Number 709-050
Event Date 08/22/1996
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Periodontist stated that he surgically uncovered pt's impacted upper right cuspid and bonded a lingual cleat to it; he also stated that this is one of the more common procedures which he performs. At a subsequent appointment, periodontist noted that pt had removed the elastomeric chain attached to the lingual cleat and that the cleat had separated from its base, leaving only the base of the lingual cleat attached to the pt's cuspid tooth. Pt's cuspid tooth had subsequently receded under the gum tissue, which required a second surgical procedure in order to replace the lingual cleat. Periodontist stated that pt's prognosis is excellent.

 
Manufacturer Narrative

D6, other #: 425 is a packaging date code which denotes the day this product was packaged. The packaging date code facilitates traceability of the product. Part number 709-050.

 
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Brand NameBONDABLE LINGUAL CLEAT
Type of DeviceORTHODONTIC, ATTACHMENT, LINGUAL
Baseline Brand NameBONDABLE LINGUAL CLEAT
Baseline Generic NameORTHODONTIC LINGUAL BRACKETS
Baseline Catalogue Number709-050
Baseline Model Number709-050
Other Baseline ID NumberNONE
Baseline Device FamilyORTHODONTIC AUXILLARIES
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Date First Marketed12/30/1981
Manufacturer (Section F)
3M UNITEK CORP.
2724 south peck road
monrovia CA 91016
Manufacturer (Section D)
3M UNITEK CORP.
2724 south peck road
monrovia CA 91016
Manufacturer (Section G)
3M UNITEK
2724 south peck rd.
monrovia CA 91016
Manufacturer Contact
marlyn scheff
2724 south peck rd
monrovia , CA 91016
(818) 574 -4496
Device Event Key40176
MDR Report Key38945
Event Key36567
Report Number2020467-1996-00010
Device Sequence Number1
Product CodeEJF
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation DENTIST
Type of Report Initial,Followup
Report Date 08/22/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number709-050
OTHER Device ID Number425
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Invalid Data
Date Manufacturer Received08/22/1996
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/08/1996 Patient Sequence Number: 1
#TreatmentTreatment Date
1,THERAPY DATES: JANUARY 1993 TO PRESENT.,

Database last updated on January 30, 2009

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