MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 16MM; DENTAL IMPLANT

Model Number	TSVH16
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight unknown / not provided.Pma/510k: k011028, k013227.
Event or Problem Description
It was reported that patient came in for screw fracture and discovered both implant and screw were fractured.Implant removed and site grafted.Tooth location # 10.
Additional Manufacturer Narrative
One impl tapered scr-v ha 3.7 mm 3.5mm 16mm (tsvh16) along with unknown screw were returned for investigation.Visual evaluation of the as returned product identified significant signs of wear and fracturing at the collar.Fracture portion of screw identified inside implant drive feature.Excessive bone tissue presented on the external threads of the implant.Pre-existing patient condition was type i (high) bone density.The devices were located on tooth site #10 (universal) for approximately 2 years.The reported event could not be recreated due to the nature of the dental device and event (fracture).Customer did not provide any x-ray or any picture.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 63558393.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 was performed for the reported lot number (63558393) for similar events, and no other complaint was identified.Based on the available information, device malfunction has occurred and the reported events were confirmed.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 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: 12086075
• Report Number: 0002023141-2021-01659
• Device Sequence Number: 3870056
• Product Code: DZE
• UDI-Device Identifier: 00889024019591
• UDI-Public: (01)00889024019591(10)63558393(17)220131
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• 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): 11/11/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: TSVH16
• Device Catalogue Number: TSVH16
• Device Lot Number: 63558393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• 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: 06/10/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2017
• 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: 83 YR
• Patient Sex: Female