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 Codes	Inflammation (1932); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Patient id not provided.
Event or Problem Description
It was reported that the implant was removed due to the bottom half becoming fractured with peri-implantitis with pain and inflammation at the site.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).One implant returned for investigation.Visual evaluation of the as returned implant (oss413) identified bone debris on external threads.Implant fractured at the threads.Functional testing could not be performed since the product was fractured.Pre-existing condition noted on the per was 'low bone density ¿ type iv'.The reported device (oss413) had been placed on tooth #21 (universal) for approximately 4 years.The implant was loaded prior to failure.X-ray & picture evaluation: x-ray or picture image was not provided.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev j - 2022/08.Information identified: contraindications, warnings, precautions and potential adverse events.Per the applicable ifu, improper techniques as well as overloading may lead to device failure.Dhr review: dhr review for the lots (2015110503) have revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Sterilization review: sterilization record was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review: complaint history review was performed for the reported lot number (2015110503) for similar events (complaint category keywords: fracture: implant ) and no other complaint was identified.Post market trending review: december 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 (oss413) did occur, and the reported event was confirmed.

• 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: 15608482
• Report Number: 0001038806-2022-01563
• Device Sequence Number: 2315269
• Product Code: DZE
• UDI-Device Identifier: 00844868013198
• UDI-Public: (01)00844868013198(17)201118(10)2015110503
• 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: 2018
• Device Explanted Year: 2022
• 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): 02/28/2023

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: Lay User/Patient
• Device Expiration Date: 11/18/2020
• Device Model Number: OSS413
• Device Catalogue Number: OSS413
• Device Lot Number: 2015110503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2015
• 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 Age: 79 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 67 KG