MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX,13MM; DENTAL IMPLANT

Model Number	TMM4B13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.Email unknown / not provided.Last name unknown / not provided.Pma/510k: k113753, k112160.Device manufacturer date unknown / not provided.
Event or Problem Description
It was reported that implant fractured when being inserted.Next appointment not reported.Symptoms of pain reported.No injury to patient other than implant being removed.Procedure was not completed using another implant.No permanent impairment.Tooth location not reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One imp tm 4.1mm mtx,13mm (tmm4b13) with mount was returned for investigation.Visual evaluation of the as returned product identified signs of use, dried blood and bone.Tip of the implant was fractured laterally along the implant length.Trabecular metal weld was broken as the tip portion was easily pulled off implant body.Product was sent to r&d for additional testing, and the result was inconclusive.However, the test summary data including sem testing have been attached with this investigation.Please see attachments.Pre-existing patient condition noted on the per was patient having type ii (moderate) bone density.The incident occurred during the clinical procedure.Tooth location is unknown.The reported event could not be recreated due to the nature of the dental device and event (fracture).X-ray or picture were not provided by customer.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number: 1228741.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number: (1228741) for similar event and no other complaint was identified.Based on the available information, device malfunction has occurred and the reported event was confirmed.The following sections have been updated: b4: date of this report.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.

• Brand Name: IMP TM 4.1MM MTX,13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11316949
• Report Number: 0002023141-2021-00370
• Device Sequence Number: 4078378
• Product Code: DZE
• UDI-Device Identifier: 00889024018822
• UDI-Public: (01)00889024018822(17)240526(10)1228741(241)TMM4B13
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 05/26/2024
• Device Model Number: TMM4B13
• Device Catalogue Number: TMM4B13
• Device Lot Number: 1228741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR