MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 5.0 MM 10 MM; DENTAL IMPLANT

Model Number	1994
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Pma/510k: k962106.
Event or Problem Description
It was reported that the implants body cannot be removed from the delivery mounts.The implants were removed and another implants were placed.Tooth location # 19.
Additional Manufacturer Narrative
Implant was returned for investigation.Visual evaluation of the returned device identified the implant had dried blood and signs of use and failed functional testing as it took excessive force to remove the mounts.No pre-existing conditions were noted on the per and the patient had unknown bone density.The reported device was intended for use on tooth #19 (universal) and were used for a single day/procedure.The customer did not provide pictures or additional evidence.Appropriate documentation was reviewed.A dhr reviews were completed for the subject lot number.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 dhrs.Lots were inspected and passed all acceptance criteria by qa.A complaint history reviews were performed for the reported lot number for similar events and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed for the implant as the device failed functional testing as it took excessive force to remove the mount.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMPL TWIST MP-1 5.0 MM 10 MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9962057
• Report Number: 0002023141-2020-00769
• Device Sequence Number: 16826409
• Product Code: DZE
• UDI-Device Identifier: 00889024013179
• UDI-Public: (01)00889024013179(17)220930(10)63757004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: 09/30/2022
• Device Model Number: 1994
• Device Catalogue Number: 1994
• Device Lot Number: 63757004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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