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	07/04/2020
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
Doctor reported the implant in tooth location 47 fractured after 7 months of placement.Implant was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A osseotite® implant 4 x 13mm (oss413) and osseotite® implant 4 x 11.5mm (oss411) were returned for investigation.Visual inspection of the as returned product identified excessive bone, bridged crown and fractured on both implants.The reported device location is # 46 and 47 and usage of length is approximately 7 months.Device history record (dhr) review was completed for the subject lot numbers (2019022021 and 2018050168).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 was 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 numbers (2019022021 and 2018050168) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur 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 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10499258
• Report Number: 0001038806-2020-01335
• Device Sequence Number: 17006740
• Product Code: DZE
• UDI-Device Identifier: 00844868013198
• UDI-Public: (01)00844868013198(17)240312(10)2019022021(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: 2019
• 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): 12/17/2020

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: 03/12/2024
• Device Model Number: OSS413
• Device Catalogue Number: OSS413
• Device Lot Number: 2019022021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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: 62 YR