MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 3.75 MM 1 0 MM; DENTAL IMPLANT

Catalog Number	1989
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).D10: 1845, hex drive seating tool.0 35 inches/lot# unknown.G4: additional pma/510(k) number ¿ k943604.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
The customer reported nerve injury; implant perforation into mental foreman and nerve damage.When the screws of the cover were tightened, the jigs bit into them and the implant could not be removed.As a treatment for the patient, the entire implant was removed.The patient is undergoing follow-up with medication treatment for nerve paralysis.Tooth site # 20.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4315.Zimvie received the reported implant for evaluation.Visual/physical evaluation of the as returned product and functional testing identified signs of use (wear) but no malfunction.Dhr review was completed for the subject lot number 2022040861.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 2022040861 for similar events and no other complaint was identified.Per the ifu, zimmer dental implants should not be placed if there is an insufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical).Implants placed in the maxilla should not perforate the sinus floor membrane.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error ¿ improper case planning.Therefore, based on the available information, device malfunction has not occurred.Additionally, the reported event could not be verified as the exact details of event were unknown/unverifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: IMPL TWIST MP-1 3.75 MM 1 0 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: 17699770
• Report Number: 0002023141-2023-02488
• Device Sequence Number: 12623942
• Product Code: DZE
• UDI-Device Identifier: 00889024013124
• UDI-Public: (01)00889024013124(17)270709(10)2022040861
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1989
• Device Lot Number: 2022040861
• 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: 09/07/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL TOOL-SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic