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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the impression coping will engage with hex of implant.However, the prosthetic screw and impression coping screw will not fully engage.Threads of implant seem to be affected.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Not enough information was provided to conduct an investigation as the product will not be returing and the item and lot number was not provided in order to do a dhr and a complaint history review.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: g4: additional pma/510(k) number k011028 | k013227.Based on the additional information received from the customer, device evaluation will be conducted.Once the investigation has been conducted, supplemental report will be submitted.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was not returned for investigation.Since products have not been returned, visual/functional inspection could not be performed.No pre-existing conditions were noted on the product experience report (per).X-ray or picture was not provided.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.Complainant reported that the threads of the implant seem to be affected.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.
Event or Problem Description
No further event information is 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
• 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: 15191137
• Report Number: 0002023141-2022-02000
• Device Sequence Number: 5902238
• Product Code: DZE
• UDI-Device Identifier: 00889024020122
• UDI-Public: (01)00889024020122(17)260721(10)1244779
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2026
• Device Model Number: TSVWH16
• Device Catalogue Number: TSVWH16
• Device Lot Number: 1244779
• Was Device Available for Evaluation?: No
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 01/10/2023
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 08/25/2022; 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male