MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 5.0 MM 8 MM; DENTAL IMPLANT

Catalog Number	1993
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A2: patient age is not provided / unknown.A4: patient weight is not provided / unknown.E1: initial reporter¿s title is not provided / unknown.G4: additional 510(k) number is k962106.
Event or Problem Description
It was reported that the implant mount did not come off.Replaced with a different implant.Tooth site # 27.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Zimvie received one (1) 1993, (impl twist mp-1 5.0 mm 8 mm) for evaluation.Visual evaluation / functional test was performed, implant shows slight wear however mount was able to disengage from implant as intended.No malfunction.Dhr review was completed for the subject lot number 2022120063.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022120063 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: functional: does not disengage/release a definitive root cause could not be determined since device malfunction did not occur.The reported event was unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, a device malfunction did not occur.The mount was able to disengage from implant as intended.The coob / event were unconfirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: IMPL TWIST MP-1 5.0 MM 8 MM
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19967300
• Report Number: 0002023141-2024-02685
• Device Sequence Number: 12986196
• Product Code: DZE
• UDI-Device Identifier: 00889024013162
• UDI-Public: (01)00889024013162(17)280227(10)2022120063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013494
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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 Catalogue Number: 1993
• Device Lot Number: 2022120063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2023
• 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
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic