MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,3.7,11.5,MTX,MG; DENTAL IMPLANT

Model Number	TMTB11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that during a clinical exam clinician discovered a fractured implant and therefore the abutment became loose.No indication if the patient will return no future appointment reported.No injury to patient other than implant being removed.No permanent impairment and no delay in procedure.
Additional Manufacturer Narrative
One imp,tsv,3.7,11.5,mtx,mg (tsvtb11) was returned for investigation (image 1-2).Visual inspection of the as returned product identified significant damage and fracturing about the implant threads and collar.No pre-existing conditions were noted on the per.The reported product was located on tooth # 19 (universal) and used for approximately 4 years.The reported event could not be recreated due to the nature of the dental device and event (fracture).Appropriate documentation was reviewed.Dhr review was completed for the subject lot number.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 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.G4: date received by manufacturer.G7: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One imp,tsv,3.7,11.5,mtx,mg (tsvtb11) was returned for investigation (image 1-2).Visual inspection of the as returned product identified significant damage and fracturing about the implant threads and collar.No pre-existing conditions were noted on the per.The reported product was located on tooth # 19 (universal) and used for approximately 4 years.The reported event could not be recreated due to the nature of the dental device and event (fracture).Appropriate documentation was reviewed.Dhr review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for the tsvtb11 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product.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.D4: lot/serial # unknown / not provided.D4: device expiration date unknown / not provided.D4: device udi number unknown / not provided.G4: date received by manufacturer.G5: pma/510(k) number unknown / not provided.G7: checked "follow-up." h2: checked follow-up type.H4: device manufacturer date unknown / not provided.H10: added manufacturer narrative.

• Brand Name: IMP,TSV,3.7,11.5,MTX,MG
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9917081
• Report Number: 0002023141-2020-00687
• Device Sequence Number: 19536640
• Product Code: DZE
• UDI-Device Identifier: 00889024019003
• UDI-Public: (01)00889024019003(17)191130(10)62893534(241)TMTB11
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2020

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: Health Professional
• Device Model Number: TMTB11
• Device Catalogue Number: TSVTB11
• Device Lot Number: 62893534
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 06/04/2020; 06/09/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 06/05/2020; 06/09/2020
• 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: 65 YR