MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,3.7,16,MTX,MG; DENTAL IMPLANT

Model Number	TSVTB16
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Last name unknown / not provided.
Event or Problem Description
It was reported that the implant in site 21 was removed due to screw holding transfer coping would not loosen and then the coping broke.Had to cut out and trephine implant from bone.Implant placed in adjacent location.Site grafted.Allograft placed with implant.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One (1) imp,tsv,3.7,16,mtx,mg (tsvtb16) was returned for investigation.Visual evaluation of the as returned implant identified signs of use, apparent minor bone attached to external threads.Screw fragment identified in drive feature - possibly the mount screw.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was high bone density (type i).The reported implant was located on tooth # 21 (universal) and was used, placed and removed on the same day.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1254032).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, were 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 (1254032) for similar events and no other complaint was identified.March post market trending was reviewed and there were no actionable events or corrective actions for the reported events (does not disengage/release & fracture mount) or product (tsvtb16).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did occur, and the reported event (fracture mount) was confirmed since, the mount screw was seen stuck in the implant's drive feature.However, device malfunction and the reported event (does not disengage/release) was non-verifiable with the information provided.

• Brand Name: IMP,TSV,3.7,16,MTX,MG
• 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: 16239977
• Report Number: 0002023141-2023-00284
• Device Sequence Number: 20471149
• Product Code: DZE
• UDI-Device Identifier: 00889024019959
• UDI-Public: (01)00889024019959(17)270418(10)1254032
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: Health Professional
• Device Model Number: TSVTB16
• Device Catalogue Number: TSVTB16
• Device Lot Number: 1254032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female