MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® IMPLANT 3.75 X 13MM; DENTAL IMPLANT

Model Number	OSS313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Email address was not provided.
Event or Problem Description
It was reported that oss313 implant placed in dental site 6 fractured.No other implant was placed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G4: date received by manufacturer.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer.H6: event problem and evaluation codes.H10: additional narrative one osseotite® implant 3.75 x 13mm (oss313) was returned for investigation.Visual evaluation of the as returned product identified signs of significant wear and debris about the threads.The device is fractured across the threads.The per indicates that the patient has a history of bruxism, which can contribute to fracture.The reported product was located on tooth # 13 (fdi) and used for approximately 12.5 years.The reported event could not be recreated due to the nature of the dental device and event (fracture).Device history record (dhr) review was completed for the subject lot number 642882.It was confirmed that all operations and inspections were executed as per the applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Therefore, based on the available information, device malfunction has occurred and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® IMPLANT 3.75 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9816795
• Report Number: 0001038806-2020-00481
• Device Sequence Number: 14220195
• Product Code: DZE
• UDI-Device Identifier: 00844868013129
• UDI-Public: (01)00844868013129(17)120314(10)642882(241)OSS313
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2012
• Device Model Number: OSS313
• Device Catalogue Number: OSS313
• Device Lot Number: 642882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR