MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 3.75 X 13MM; DENTAL IMPLANT

Model Number	OSS313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Patient identifier unknown / not provided, patient sex unknown / not provided, weight unknown / not provided, email address unknown / not provided.
Event or Problem Description
It was reported that the implant was removed due to implant fracture at implant collar.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite implant 3.75 x 13mm (oss313) with crown attached was returned for investigation.Visual evaluation of the as returned implant identified bone debris on external threads.Implant fractured at the threads.Platform was not returned.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 #unk for approximately 3 years.Dhr review for the lot number (2019031346) had revealed no deviations nor non-conformance's 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 (2019031346) for similar events (complaint category keywords: fracture: implant) and one other complaint was identified.Investigation has yet to be completed and results are not available at this time.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.
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).Zimvie received one (1) oss313, (osseotite implant 3.75 x 13mm) for evaluation.Visual evaluation was performed, there was bone debris on the external threads.There was damage identified.The implants collar was fractured.Dhr review was completed for the subject lot number 2019031346.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2019031346 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : implant.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was missing or confusing instructions for use, the material selection of implant inadequate (unable to withstand occlusal forces or long term loading).Therefore, based on the available information, a device malfunction did occur.The implants collar was fractured.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE IMPLANT 3.75 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: 16350332
• Report Number: 0001038806-2023-00267
• Device Sequence Number: 12337317
• Product Code: DZE
• UDI-Device Identifier: 00844868013129
• UDI-Public: (01)00844868013129(17)240402(10)2019031346
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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: Other
• Device Expiration Date: 04/01/2024
• Device Model Number: OSS313
• Device Catalogue Number: OSS313
• Device Lot Number: 2019031346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 05/04/2023; 05/04/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 05/18/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic