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	Wound Dehiscence (1154); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Pma/510k: k011028, k013227.
Event or Problem Description
The clinician reported "developed dehiscence".The patient states that he started feeling soreness and puffiness around the buccal site #5 implant, one week after surgery.The patient has developed a vertical cleft type dehiscence.After consult with a periodontist, it was decided to remove the implant and place later.
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 implant identified no apparent signs of malfunction.Bone residue was identified around the external threads and vent due to usage.Functional testing could not be performed for the reported medical condition (developed dehiscence).However, measurements were taken.Through dimensional analysis and comparison the device was determined to be within design specification.Pre-existing condition noted on the per was low bone density ¿type iii.The reported device had been placed on tooth #5 (universal) for approximately 1 month.X-ray & picture evaluation: none provided.Appropriate documentation was reviewed.Dhr review for the lot (63769063) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (63769063) for similar events (complaint category keywords: medical: other (developed dehiscence) and no other complaint was identified.Based on the available information, device malfunction did not occur.However, the reported event could not be verified as the exact details of event and patient anatomical conditions were unknown/nonverifiable.
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: 12005889
• Report Number: 0002023141-2021-01541
• Device Sequence Number: 3196991
• Product Code: DZE
• UDI-Device Identifier: 00889024020122
• UDI-Public: (01)00889024020122(17)221031(10)63769063
• 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: 2021
• 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): 10/14/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Model Number: TSVWH16
• Device Catalogue Number: TSVWH16
• Device Lot Number: 63769063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 10/14/2021
• 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: 60 YR