MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,3.7MM,16M; DENTAL IMPLANT

Model Number	TSVMB16
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Headache (1880); Discomfort (2330)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported allergic reaction to titanium and was removed.Discomfort and headache were reported as a result of the event.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.Email address unknown / not provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One imp, tsv, mcol mg,3.7mm,16m (tsvmb16) was returned for investigation.Visual evaluation of the as returned product identified signs of use but no apparent signs of malfunction.Functional testing could not be performed for the reported event (allergic reaction).Measurements were taken using cal3845.Following dimensional analysis and comparison to drawings, the device was determined to be within design specification.Device history record (dhr) review for the lot (1233788) 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 (1233788) for similar events (complaint category keywords: medical: allergic reaction) and no other complaint was identified.Therefore, based on the available information, device malfunction did not occur.The reported event could not be verified as the exact details of event were nonverifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMP,TSV,MCOL MG,3.7MM,16M
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13042079
• Report Number: 0002023141-2021-03675
• Device Sequence Number: 5364541
• Product Code: DZE
• UDI-Device Identifier: 00889024019751
• UDI-Public: (01)00889024019751(17)241123(10)1233788
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111889
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/23/2024
• Device Model Number: TSVMB16
• Device Catalogue Number: TSVMB16
• Device Lot Number: 1233788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• 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: 11/30/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male