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

Model Number	SPMB12
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Pma/510(k) number: k011245 and k002188.
Event or Problem Description
It was reported the implant fractured at the moment of implant placement.Doctor placed other implant in the same surgery.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Two (2) impl tapered sp 3.7mm 12m m hexagon (spmb12) were returned for investigation.Visual evaluation of the as returned product identified both implants fractured around the collar region.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 keyword category (functional: fracture : implant) and no other complaint was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
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
• MDR Report Key: 11601106
• Report Number: 0002023141-2021-00808
• Device Sequence Number: 14504550
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 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: 03/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR