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

Model Number	TMTB16
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that the implant broke during placement.No injury to patient other than implant being removed.No permanent impairment nothing else reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One trabecular metal implant (tmtb16) was not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use (ifu), risk files and other available information.Functional testing could not be performed since the product was not returned.No pre-existing conditions were reported.The reported devices had been placed on an unknown tooth location for an unknown period of time.X-ray & picture evaluation was not provided.Appropriate documentation was reviewed.Dhr review for the lot (63390569) 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 (63390569) and one similar event or complaint was identified ¿ (b)(4).Based on the available information, device malfunction and the reported event could not be verified since the product was not returned.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "yes" to "no".H6: entered evaluation codes.H10: added manufacturer narrative h3 other text : device not returned.

• 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: 11315722
• Report Number: 0002023141-2021-00369
• Device Sequence Number: 17163308
• Product Code: DZE
• UDI-Device Identifier: 00889024019027
• UDI-Public: (01)00889024019027(17)210630(10)63380689(241)TMTB16
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/20/2021

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: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: TMTB16
• Device Catalogue Number: TMTB16
• Device Lot Number: 63390569
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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