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

Model Number	1994
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.G4: k962106.
Event or Problem Description
It was reported that healing screw stops halfway.After placing the implant, the doctor tried to attach the healing screw, but it stopped halfway.He tried another one and it stopped as well.No health hazard.Tooth site # 18.
Additional Manufacturer Narrative
Zimvie received one (1) 1994, (impl twist mp-1 5.0 mm 10 mm) for evaluation.Visual evaluation was performed, the healing screws have signs of use, and the threads were damaged, and do not seat on the implant.Dhr review was completed for the subject lot number 2022011363.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 2022011363 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : fit : does not seat.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-002j2, the most likely root cause determined from the investigation was insufficient instructions for use, insufficient training, inadequate instrumentation, inadequate packaging.Therefore, based on the available information, a device malfunction did occur.The healing screws have signs of use, and the threads were damaged, and do not seat on the implant.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.The following sections have been updated: b4: date of this report.D9: device availability.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 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
• 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 ; 5619713230
• MDR Report Key: 17076159
• Report Number: 0002023141-2023-01599
• Device Sequence Number: 2188420
• Product Code: DZE
• UDI-Device Identifier: 00889024013179
• UDI-Public: (01)00889024013179(17)270318(10)2022011363
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: Other
• Device Model Number: 1994
• Device Catalogue Number: 1994
• Device Lot Number: 2022011363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic