MAUDE Adverse Event Report: ZIMMER DENTAL TWIST HA 3.25MMX10MM; DENTAL IMPLANT

Model Number	2130
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight 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 placed.Tooth site #25.No delay or injury.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One twist ha 3.25mmx10mm (2130) was returned for investigation (image 1-3).Visual inspection of the as returned product identified minimal signs of wear about the implant body, mount, screw, and tines.No pre-existing conditions were noted on the per.The reported product was located on tooth # 25 (universal) and removed the same day.The reported event could not be recreated when the product was functionally tested.The mount disengaged as normal using appropriate hand tools.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 2019090500.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 (2019090500) for similar event and no other complaint was identified.Based on the available information, device malfunction has not occurred and the reported event was unconfirmed.

• Brand Name: TWIST HA 3.25MMX10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10692304
• Report Number: 0002023141-2020-01696
• Device Sequence Number: 3907591
• Product Code: DZE
• UDI-Device Identifier: 00889024013285
• UDI-Public: (01)00889024013285(17)240912(10)2019090500(241)2130-LZ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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: Lay User/Patient
• Device Expiration Date: 09/12/2024
• Device Model Number: 2130
• Device Catalogue Number: 2130
• Device Lot Number: 2019090500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR