MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ IMPLANT 5 X 11.5MM; DENTAL IMPLANT

Model Number	OSS511
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age at time of the event unknown / not provided.Patient weight unknown / not provided.Reporter name unknown / not provided.
Event or Problem Description
It was reported that implants at tooth sites 24 and 27 fractured and were removed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative one osseotite implant 4 x 11.5mm (oss411) and one osseotite implant 5 x 11.5mm (oss511) were returned for investigation.Visual evaluation of the as returned implant bone debris and signs of usage.Implant (oss411) was fractured at threads.Fractured piece not returned.The abutment screw detached from implant.No fracture was detected for the oss511 implant.Functional testing could not be performed since the product was fractured.Pre-existing condition noted on the per was unknown bone density.The reported device had been placed on tooth #24 and 27 (fdi) for approximately 7 years.Dhr review for the lot number (2016050540 and 2016022064) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Products was conforming at the time it left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2016050540 and 2016022064) for similar events (complaint category keywords: fracture: implant) and no other complaint was identified.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.Fracture of oss511 was unconfirmed.

• Brand Name: OSSEOTITE¿ IMPLANT 5 X 11.5MM
• 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: 16453050
• Report Number: 0001038806-2023-00381
• Device Sequence Number: 5835049
• Product Code: DZE
• UDI-Device Identifier: 00844868013266
• UDI-Public: (01)00844868013266(17)210405(10)2016022064
• 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: 2016
• Device Explanted Year: 2023
• 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): 06/07/2023

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: 04/05/2021
• Device Model Number: OSS511
• Device Catalogue Number: OSS511
• Device Lot Number: 2016022064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2016
• 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