MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® CERTAIN® 2 IMPLANT 5 X 10MM; DENTAL IMPLANT

Model Number	XIFOSS510
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Patient weight is not provided / unknown.Initial reporter¿s title and last name are not provided / unknown.
Event or Problem Description
It was reported that while placing the implant, the threads was stripped and the implant overturned.Tooth # 30.The site was grafted prior to original implant placement.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d4: expiration date and unique identifier (udi) number; h2: if follow-up, what type; h3: device evaluated by manufacturer; h4: device manufacturer date; h6: type of investigation; h6: investigation findings; h6: investigation conclusions; h10: additional narratives/data.The implant was returned, and the reported event (damaged threads) was confirmed.Based on the evaluation, device malfunction has occurred for the implant.There is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported events or devices.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the products were within specifications and conforming when they left zimvie.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedures.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.A definitive root cause could not be determined.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® CERTAIN® 2 IMPLANT 5 X 10MM
• 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: 15329265
• Report Number: 0001038806-2022-01344
• Device Sequence Number: 6362188
• Product Code: DZE
• UDI-Device Identifier: 00844868023210
• UDI-Public: (01)00844868023210(17)230508(10)2018050048
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K100724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: XIFOSS510
• Device Catalogue Number: XIFOSS510
• Device Lot Number: 2018050048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 01/28/2023
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2018
• 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: 71 YR
• Patient Sex: Male