MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 3.7MM 12M M HEXAGON; DENTAL IMPLANT

Model Number	SPMB12
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Pma/510(k): k011245 and k002188.
Event or Problem Description
It was reported that during the dental surgical procedure he realized that within the sterile packaging, the implant was not tight to the mounting device.The implant was loose.The doctor confirms that the procedure was completed with another implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A impl tapered sp 3.7mm 12m m hexagon (spmb12) was returned for investigation.Visual inspection of the as returned product identified no signs of use and not attached to the bundled mount.Separated upon receipt and package not sealed.Functional testing was performed on the returned implant and mount.They engaged and disengaged as intended, however testing to recreated the reported event could not be performed as the conditions of the device when it arrived with the customer cannot be recreated.Device history record (dhr) review was completed for the subject lot number (2019110202).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 (2019110202) for similar event and no other complaint was identified.Based on the available information, device malfunction could did not occur and the reported event was non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMPL TAPERED SP 3.7MM 12M M HEXAGON
• 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: 12923457
• Report Number: 0002023141-2021-03470
• Device Sequence Number: 11988707
• Product Code: DZE
• UDI-Device Identifier: 00889024017474
• UDI-Public: (01)00889024017474(17)241108(10)2019110202
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 11/08/2024
• Device Model Number: SPMB12
• Device Catalogue Number: SPMB12
• Device Lot Number: 2019110202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2019
• 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
• Patient Age: 49 YR
• Patient Sex: Male