MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 6/5 X 13MM; DENTAL IMPLANT

Model Number	XIITP6513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant at tooth site #19 was removed due to pain.
Event or Problem Description
No additional event information at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: tyoe of investigation codes were added: 4109, 4110, 4111 and 3331.H6: investigation findings code was added: 213 h6: investigation conclusions code was added: 67.One osseotite® tapered certain® prevail® implant 6/5 x 13mm (xiitp6513) was returned for investigation.Visual evaluation of the as returned product identified signs of usage but no significant damage was identified.Measurements could not be taken due to excessive bone debris on the implant.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was type ii (moderate) bone density.The reported device was located on tooth #19 (universal) and was used for approximately 2 years and 5 months.Dhr review for the lot number (2018041976) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Sterilization record ((b)(4)) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review by lot number (2018041976) was performed for similar events using keyword medical pain and no other similar complaint was identified.August post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur and the reported event was non-verifiable.

• Brand Name: OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 6/5 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12124692
• Report Number: 0001038806-2021-01179
• Device Sequence Number: 14538423
• Product Code: DZE
• UDI-Device Identifier: 00844868022220
• UDI-Public: (01)00844868022220(17)230509(10)2018041976
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2023
• Device Model Number: XIITP6513
• Device Catalogue Number: XIITP6513
• Device Lot Number: 2018041976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 10/27/2021
• 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