MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 16MM; DENTAL IMPLANT

Model Number	TSVWH16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Patient weight: not provided.Event date: not provided.Additional pma/510(k) number: k011028, k013227.
Event or Problem Description
It was reported that implant (tsvwh16) was requested to be removed due to patient complaining of constant inflamed gum tissue and pain at tooth location 28.
Additional Manufacturer Narrative
One impl tapered scr-v ha 4.7 mm 4.5mm 16mm (tsvwh16) was returned for investigation.Visual evaluation of the as returned product identified moderate wear about the implant body and threads.Product matched print specification where measured.No pre-existing conditions were noted on the per.The reported product was located on tooth # 28 and used for approximately 22 months.The reported event could not be recreated due to the nature of the dental device and event (medical conditions).The customer has not provided additional pictures or x-ray images of the product.Dhr review was completed for the subject lot number 64001387.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 (64001387) for similar event and no other complaint was identified.August post market trending was reviewed and there were no actionable events or corrective actions for the reported events (inflammation + patient pain) or product (tsvwh16).Therefore, based on the available information, device malfunction has not occurred and the reported events were non-verifiable.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 16MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10379632
• Report Number: 0002023141-2020-01216
• Device Sequence Number: 2942464
• Product Code: DZE
• UDI-Device Identifier: 00889024020122
• UDI-Public: (01)00889024020122(17)230430(10)64001387(241)TSVWH16
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 04/30/2023
• Device Model Number: TSVWH16
• Device Catalogue Number: TSVWH16
• Device Lot Number: 64001387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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: 70 YR