MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX,10MM; DENTAL IMPLANT

Catalog Number	TMM4B10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Paresthesia (4421)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A2: age at time of the event unknown / not provided.A4: patient weight unknown / not provided.D10.Concomitant medical products tsvb10, impl tapered scr-v sbm 3.7mm 3.5mm 10mm, lot 1221079.
Event or Problem Description
It was reported that the implants caused nerve injury and had to be removed.Pain and paresthesia were reported as a result of the event.Patient will have to return to place new implants.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4) zimvie received one (1) tsvb10, (impl tapered scr-v sbm 3.7mm 3.5mm 10mm) and one (1) tmm4b10 (imp tm 4.1mm mtx,10mm) for evaluation.Visual evaluation was performed, the tsvb10 was returned in three (3) pieces.Follow up determined that the damage was attributed to the removal of the devices.No other malfunctions were detected.Regarding the returned tmm4b10.There was bone debris on the external threads.There were no signs of malfunction that would contribute to the event.The implant matched print specifications.The implant was measured by using caliper.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product is not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the tmm4b10 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Review completed utilizing keywords: dental : medical : nerve damage.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was missing or confusing instructions for use or inadequate treatment planning.However, a definitive root cause could not be identified.Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable.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.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Device was measured with a caliper and identified as a tmm4b10.After follow up on 20 oct 2023, tmm4b10 was reported as the correct reference, lot number not available.

• Brand Name: IMP TM 4.1MM MTX,10MM
• 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: 17859729
• Report Number: 0002023141-2023-02731
• Device Sequence Number: 12188735
• Product Code: DZE
• UDI-Device Identifier: 00889024018860
• UDI-Public: (01)00889024018860(17)240602(10)1228805
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K132258
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2023

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: Lay User/Patient
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: TMM4B10
• Device Lot Number: 1228805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/02/2023; 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic