MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TM,3.7MMX16MML,MTX FU; DENTAL IMPLANT

Model Number	TMTB16
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number cmp- (b)(4).
Event or Problem Description
It was reported that fixture mount could not be removed within routine torque force, lead to loss if primary stability at the surgical site.Another implant was placed.Tooth site # 21.
Additional Manufacturer Narrative
One trabecular metal implant (tmtb16) and mount were reported but not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use and risk files.Functional testing could not be performed since the products were not returned.Pre-existing condition noted on the per was moderate bone density ¿ type ii.The reported devices were being placed on tooth# 21 (fdi) when the incident occurred.X-ray & picture evaluation: not provided.Appropriate documentation was reviewed.Dhr review for the lot (63534510) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (63534510) for similar events (complaint category keyword: does not disengage/release) and no other complaint was identified.Based on the available information, device malfunction and the reported event could not be verified since the products were not returned.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One trabecular metal implant (tmtb16) and mount were returned for investigation.Visual evaluation of the as returned products identified minor signs of wear due to usage but no apparent sign of malfunction.Functional testing was conducted.The devices were able to engage/disengage as normal.Pre-existing condition noted on the per was moderate bone density ¿ type ii.The reported devices were being placed on tooth# 21 (fdi) when the incident occurred.X-ray & picture evaluation, not provided.Appropriate documentation was reviewed.Dhr review for the lot (63534510) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (63534510) for similar events (complaint category keyword: does not disengage/release) and no other complaint was identified.Based on the available information and functional testing, device malfunction did not occur and the reported event was unconfirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP,TM,3.7MMX16MML,MTX FU
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11434652
• Report Number: 0002023141-2021-00559
• Device Sequence Number: 3105662
• Product Code: DZE
• UDI-Device Identifier: 00889024019027
• UDI-Public: (01)00889024019027(17)211231(10)63534510
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: company representative,foreig
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: TMTB16
• Device Catalogue Number: TMTB16
• Device Lot Number: 63534510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 06/17/2021; 08/20/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 06/22/2021; 08/26/2021
• 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: 48 YR
• Patient Weight: 65