MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	OSS413
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that the implant oss413 at tooth site #46 was removed because it fractured.
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: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.One osseotite® implant 4 x 13mm (oss413) was returned for investigation.Visual evaluation of the as returned product identified the implant completely fractured below the collar, at the threads section.The non-reported screw was also returned and was seen with damage on the hex part.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.(fractured).A pre-existing condition noted on the per was low bone density (type ii).The reported device was located on tooth 46 (fdi) and was used for approximately 14 years 9 months.Dhr review was completed for the subject lot number (406923).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (406923) for similar events and no other complaint was identified.(b)(6) post market trending was reviewed and there were no actionable events or corrective actions for the reported event (implant fractured) or product (oss413).Therefore, based on the available information, device malfunction did occur and the reported event was confirmed as physical evaluation identified the fractured implant.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10424780
• Report Number: 0001038806-2020-01180
• Device Sequence Number: 14137647
• Product Code: DZE
• UDI-Device Identifier: 00844868013198
• UDI-Public: (01)00844868013198(17)100629(10)406923(241)OSS413
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: Lay User/Patient
• Device Expiration Date: 06/29/2010
• Device Model Number: OSS413
• Device Catalogue Number: OSS413
• Device Lot Number: 406923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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: 63 YR