MAUDE Adverse Event Report: ZIMMER DENTAL IMPL SCR-V SBM 4.7MM 4.5M M 10MM; DENTAL IMPLANT

Model Number	SVWB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp(b)(4).Pma/510(k) number: k011028 and k013227.
Event or Problem Description
It was reported that the implant was removed due to fracture.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.One impl scr-v sbm 4.7mm 4.5m m 10mm (svwb10) implant was returned for investigation.Visual evaluation of the as returned implant identified fracture at the collar.There was bone residue around the external threads of the implant.Pre-existing patient condition noted on the product experience report (per) includes good oral hygiene.The reported device had been placed for approximately 4 years.The reported event could not be recreated due to the nature of the dental device and event (fracture).X-ray and picture images were not provided.Documents reviewed: instructions for use - tapered screw-vent and trabecular metal implants, ifu4869 rev 9-10/19.Instructions for use ¿ prosthetics for zimmer dental implant systems ¿ ifu4894 rev 6 ¿ 08/19.Information identified: contraindications & precautions (pages 3 & 4).Per the applicable ifu, patient factors such as severe bruxism, clenching, and overloading, may cause component fracture.Device history record (dhr) review was completed for the subject lot number (63618456).It was confirmed that all operations and inspections were executed as per applicable procedures.No deviations or non-conformances, which could have caused or contributed to the reported event were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was completed for the subject lot number (63618456) and no other complaints about nonconforming products were identified.December post market trending was reviewed and there were no actionable trends or corrective actions for the reported devices and events.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMPL SCR-V SBM 4.7MM 4.5M M 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10926909
• Report Number: 0002023141-2020-02133
• Device Sequence Number: 3241300
• Product Code: DZE
• UDI-Device Identifier: 00889024018259
• UDI-Public: (01)00889024018259(10)63618456(17)220331
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: SVWB10
• Device Catalogue Number: SVWB10
• Device Lot Number: 63618456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 02/24/2021; 04/30/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 03/03/2021; 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 66