MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7,10,MTX,MC,MG,HA; DENTAL IMPLANT

Model Number	TSVMWH10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Catalog, lot number, expiration date and unique identifier (udi) number unknown / not provided.Additional pma/510(k) number ¿ k133339.Device manufacturer date unknown / not provided.
Event or Problem Description
It was reported that the implant body cannot be removed from the fixture mount.The implant was removed and another implant was placed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp-(b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified the implant with signs of use.Functional testing to recreate the reported event; verified the implant was unable to disengage/release from the mount.No pre-existing conditions were noted on the product experience report (per).The patient was reported to have high density (type i) bone.The reported device was located on tooth # 19 and was placed and removed on the same day.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 was one related complaints for this product lot.Complainant reported that the implant body could not be removed from the fixture mount.The reported complaint was confirmed.A definitive root cause for this complaint could not be determined.

• Brand Name: IMP, TSV, 4.7,10,MTX,MC,MG,HA
• 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: 14175181
• Report Number: 0002023141-2022-00960
• Device Sequence Number: 4293148
• Product Code: DZE
• UDI-Device Identifier: 00889024344143
• UDI-Public: (01)00889024344143(17)260216(10)1241578
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: 02/16/2026
• Device Model Number: TSVMWH10
• Device Catalogue Number: TSVMWH10
• Device Lot Number: 1241578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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: 52 YR
• Patient Sex: Male