MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.7,16,MTX,MG; DENTAL IMPLANT

Model Number	TSVTWB16
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Medical product- hc455, heal collar 4.5x5.5, 5mm, lot# 2021021336.Medical product- hc455, heal collar 4.5x5.5, 5mm, 2020120441.Additional pma/510(k) number ¿ k101880.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Customer reported that the implant was placed but had issues with two (2) healing abutments that did not fit.The implant was stripped inside and caused the healing collars to be bent.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: investigation type codes were added: 3331, 4109, 4110 and 4111.H6: investigation findings code was added: 180.H6: investigation conclusions codes were added: 4307.H10: narrative/data was updated.One tapered screw vent (tsvtwb16) and two heal collar 4.5x5.5, 5mm (hc455) were returned for investigation.Visual evaluation of the as returned products indicated significant signs of somewhat damage on the internal drive feature of implant most likely multiple attempts and threads of healing collar identified damaged as well.Bent was not identified on the returned healing collars.Functional testing was performed for the returned products and the devices could not seat as intended.Dhr review was completed for the subject lot numbers 1241292, 2021021336 and 2020120441.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 by lot numbers (1241292, 2021021336 and 2020120441) was performed for similar events using keyword (damaged threads, does not seat and bent) and no other similar complaint was identified.December post market trending was reviewed and there were no actionable events or corrective actions for the reported events or product (tsvtwb16 and hc455).Therefore, based on the available information, device malfunction did occur and the reported event was confirmed for damaged threads and does not seat, however, reported event for bent was unconfirmed as malfunction did not occur.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: IMP,TSV,4.7,16,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: 12527382
• Report Number: 0002023141-2021-02670
• Device Sequence Number: 4460636
• Product Code: DZE
• UDI-Device Identifier: 00889024020023
• UDI-Public: (01)00889024020023(17)251207(10)1241292
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2025
• Device Model Number: TSVTWB16
• Device Catalogue Number: TSVTWB16
• Device Lot Number: 1241292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT-SEE H10 NARRATIVE; DENTAL ABUTMENT-SEE H10 NARRATIVE; DENTAL ABUTMENT; DENTAL ABUTMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 91 KG