MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM; DENTAL IMPLANT

Model Number	TSV6B13
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Pma/510k: k011028, k013227.
Event or Problem Description
It was reported that the internal implant threads were damaged during a clinical procedure and is requesting tool item # 0493 to be sent out.The implant # 2 is well seated and intact.As a result of this event, no injury to the patient was reported.
Additional Manufacturer Narrative
One tapered screw-vent implant (tsv6b13) was reported but not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was conducted using applicable instructions for use, risk files and other available information.Functional testing could not be performed since the device was not returned.No pre-existing conditions were noted on the per.The reported device was intended for tooth # 2 (unknown notation system).X-ray/picture images were not provided.Appropriate documentation was reviewed.Dhr review for the lot (1219053) 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 (1219053) for similar events and no other complaint was identified.Based on the available information, device malfunction and the reported event could not be verified.H3 other text : device not returned.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM
• 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: 12682340
• Report Number: 0002023141-2021-02982
• Device Sequence Number: 19134482
• Product Code: DZE
• UDI-Device Identifier: 00889024019393
• UDI-Public: (01)00889024019393(17)230819(10)1219053
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/20/2022

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: 08/19/2023
• Device Model Number: TSV6B13
• Device Catalogue Number: TSV6B13
• Device Lot Number: 1219053
• Was Device Available for Evaluation?: No
• 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: 10/08/2021
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose