MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V HA 6MM 5.7MM 13MM; DENTAL IMPLANT

Catalog Number	TSV6H13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number cmp (b)(4).A4: patient weight unknown / not provided.B3: date of event unknown / not provided.G4: additional pma/510(k) number k011028, k013227.
Event or Problem Description
It was reported pt called the next day after implant placement saying she was still very numb.Got pt in and removed implant.Symptoms as a result of the event: paresthesia.
Additional Manufacturer Narrative
Zimvie received one (1) tsv6h13, (impl tapered scr-v ha 6mm 5.7mm 13mm) for evaluation.Visual evaluation of the as returned device identified the implant with minor signs of use.The implant was returned with no apparent damage / malfunction that would cause or contribute to the reported event.Measurements match drawing.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 63632557.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 63632557 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿nerve damage¿.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rmf rm-00541-haz rev.4, the most likely root cause determined from the investigation is inadequate treatment planning.Therefore, based on the available information, a device malfunction did not occur.The reported event was non-verifiable with all the available information.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.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.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H4.Device manufacture date.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 TAPERED SCR-V HA 6MM 5.7MM 13MM
• 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: 20071492
• Report Number: 0002023141-2024-02806
• Device Sequence Number: 16902896
• Product Code: DZE
• UDI-Device Identifier: 00889024019478
• UDI-Public: (01)00889024019478(17)220430(10)63632557
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 04/29/2022
• Device Catalogue Number: TSV6H13
• Device Lot Number: 63632557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• 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: 08/26/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic