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

Model Number	OSS413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteolysis (2377)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported fracture of the alveolus wall during implant placement.The doctor also reported bone loss.Procedure was not completed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem d4: expiration date g3: date received by the manufacturer h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h4: device manufacture date h6: evaluation codes h10: additional narrative.One implant was returned for investigation.Visual evaluation of the as returned product identified signs of wear/use but no apparent signs of malfunction.The implant could not be functionally tested for the reported event (bone fracture/bone loss).Therefore, the reported event could not be recreated.Measurements were taken using cal1831 (due date: sep 2, 2022).Through dimensional analysis and comparison to drawings, the device was determined to be within design specification.Pre-existing condition noted on the per was 'high bone density ¿ type i'.The implant was being placed on tooth 42 (fdi) when the incident occurred.Picture/x-ray evaluation: none provided.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev i - 2022/04/01.Information identified: contraindications, warnings, precautions, and potential adverse events.Per the applicable ifu, under the section 'precautions', it is stated that improper technique can lead to implant failure and loss of supporting bone.Dhr review: dhr review for the lot (2021050240) 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.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2021050240) for similar events (complaint category keywords: medical: bone fracture & bone loss) and no other complaint was identified.Post market trending review: april post market trending was reviewed and there were no actionable events or corrective actions for the reported events or product.Therefore, based on the available information, device malfunction did not occur.Additionally, the reported events could not be verified with the information provided.

• 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
• 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: 13597396
• Report Number: 0001038806-2022-00280
• Device Sequence Number: 5848765
• Product Code: DZE
• UDI-Device Identifier: 00844868013198
• UDI-Public: (01)00844868013198(17)260522(10)2021050240
• Combination Product (Y/N): N
• Initial Reporter Country: AG
• PMA/510(K) Number: K063286
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: Health Professional
• Device Expiration Date: 05/22/2026
• Device Model Number: OSS413
• Device Catalogue Number: OSS413
• Device Lot Number: 2021050240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• 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: 02/10/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female