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

Model Number	SVH13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Weight unknown / not provided.Pma/510(k): k011028, k013227.
Event or Problem Description
It was reported that the platform fractured, crown came off, implant at tooth site #20 implant was removed and site grafted.Patient returning for implant re-placement.As a result of this event, no injury to the patient reported.Symptoms as a result of the event: none reported.
Additional Manufacturer Narrative
A impl scr-v ha 3.7mm 3.5mm 13mm (svh13) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.Pre-existing conditions noted on the per is smoker/tobacco use.The reported device was located on tooth # 20 and was used for approximately 4 years.X-ray images were provided by the customer, see image x.The x-ray image shows the product fractured.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (63275738).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 (63275738) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed by the x-ray provided.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMPL SCR-V HA 3.7MM 3.5MM 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11282310
• Report Number: 0002023141-2021-00288
• Device Sequence Number: 19794104
• Product Code: DZE
• UDI-Device Identifier: 00889024018099
• UDI-Public: (01)00889024018099(17)210131(10)63276738
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted 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): 05/14/2021

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: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: SVH13
• Device Catalogue Number: SVH13
• Device Lot Number: 63275738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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: 64 YR