MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN 2 IMPLANT 4 X 13MM; DENTAL IMPLANT

Catalog Number	XIFOSS413
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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.Gender unknown / not provided.Patient weight unknown / not provided.Date of event unknown / not provided.Brand name unknown / provided.Additional device information unknown / not provided.Premarket identification unknown / not provided.Device manufacturer date unknown / not provided.Since the lot number and device will not be returned , identifying a definitive root cause will not be possible.Should additional information be received which indicated that the device may have caused or contributed to the event, an additional report would be submitted.
Event or Problem Description
Doctor reported implant collar fracture.The implant is still in the mouth of the severely cancer-stricken patient, who is currently undergoing chemotherapy.
Event or Problem Description
Upon receipt of per form and product on 04 apr 2023 doctor also reported pain at tooth site 46.Patient has been rescheduled for new implant placement.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Investigation summary it was reported that implant collar fracture.Zimvie received one (1) xifoss413, (osseotite certain 2 implant 4 x 13mm) for evaluation.Visual evaluation was performed, excessive bone and a fracture has been identified on the implants collar.Dhr review was completed for the subject lot number 2018031702.No deviations or non-conformance's, 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 2018031702 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : fracture : implant¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation were 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 fracture has been identified on the collar.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 CERTAIN 2 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: 16660106
• Report Number: 0001038806-2023-00655
• Device Sequence Number: 1789936
• Product Code: DZE
• UDI-Device Identifier: 00844868023166
• UDI-Public: (01)00844868023166(17)230406(10)2018031702
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100724
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2023

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: 04/06/2023
• Device Catalogue Number: XIFOSS413
• Device Lot Number: 2018031702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 04/04/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/19/2023; 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 76 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic