MAUDE Adverse Event Report: ZIMMER DENTAL IMPL SCR-V SBM 3.7MM 3.5M M 13MM; DENTAL IMPLANT

Model Number	SVB13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.Last name unknown / not provided.Pma/510(k) number k011028 and k013227.
Event or Problem Description
It was reported the implant fractured and was removed.Patient felt discomfort.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One impl scr-v sbm 3.7mm 3.5m m 13mm (svb13) was returned for investigation.Visual evaluation of the as returned product identified significant signs of wear and fracturing at the collar.Bone debris presented on the outside threads of the implant.Pre-existing patient condition noted on the per was type i (high) bone density.Tooth location is 46 (fdi) and was placed for approximately 3 years and 9 months.The reported event could not be recreated due to the nature of the dental device and event (fracture).Device history record (dhr) review was completed for the subject lot number 63325683.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 (63325683) for similar event keyword category (functional: fracture : implant) and no other complaint was identified.September post market trending was reviewed and there were no actionable trends or corrective actions for the reported device (svb13) and event (implant fracture).Therefore, based on the available information, device malfunction has occurred 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 SCR-V SBM 3.7MM 3.5M M 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: 12335553
• Report Number: 0002023141-2021-02170
• Device Sequence Number: 2753816
• Product Code: DZE
• UDI-Device Identifier: 00889024018037
• UDI-Public: (01)00889024018037(17)210430(10)63325683
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• 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): 11/25/2021

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: 04/30/2021
• Device Model Number: SVB13
• Device Catalogue Number: SVB13
• Device Lot Number: 63325683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• 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: 07/29/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 48 YR
• Patient Sex: Male