MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 15MM; DENTAL IMPLANT

Model Number	XIITP5415
Medical Device Problem Codes	Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Sinus Perforation (2277)
Date of Event	07/28/2021
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 site #13 was removed due to sinus perforation.Lack of primary stability and non-integration were also reported.The site was grafted with allograft along with implant placement.Symptoms as a result of the event: inflammation and 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: type of investigation code was added: 3331, 4109, 4110 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 67.H10: narrative/data was updated.One osseotite® tapered certain® prevail® implant (xiitp5415) was returned for investigation.Visual evaluation of the as returned implant identified signs of wear/use but no apparent signs of malfunction.The device could not be functionally tested for the reported failure/event (perforated sinus).However, measurements were taken using a caliper.Following dimensional analysis and comparison to drawings, the device was determined to be within design specifications.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review for the lot (2018090896) revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Complaint history review was performed for the reported lot number (2018090896) for similar events (complaint category keywords: non integration : perforated sinus) and no other complaint was identified.A definitive root cause could not be determined.However, based on the investigation, risk review and ifu, the most likely cause determined is placement of implant in a patient with patient factors or improper techniques use during placement.Therefore, based on the available information and dimensional analysis, device malfunction did not occur.The reported event could not be verified as the exact details of event and patient anatomical conditions were unknown/nonverifiable.No further investigation or immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 15MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12490607
• Report Number: 0001038806-2021-01771
• Device Sequence Number: 14479462
• Product Code: DZE
• UDI-Device Identifier: 00844868022183
• UDI-Public: (01)00844868022183(17)230926(10)2018090896
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: Lay User/Patient
• Device Expiration Date: 09/26/2023
• Device Model Number: XIITP5415
• Device Catalogue Number: XIITP5415
• Device Lot Number: 2018090896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male