MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7,10,MTX,MC,MG,HA; DENTAL IMPLANT

Catalog Number	TSVMWH10
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that mount did not come off.After the implant was inserted, the mount axis could not be removed and it was removed and re-implanted with the same size from stock.He tried to remove it after the surgery but it would not come off.Procedure completed with another same size.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age and date of birth unknown / not provided.A4: patient weight unknown / not provided.G4: pma/510(k) number k133339.
Additional Manufacturer Narrative
Zimvie received one (1) tsvmwh10, (imp, tsv, 4.7,10, mtx, mc, mg, ha) for evaluation.Visual evaluation of the as returned devices identified the implant and bundle mount with signs of use.The returned implant was outside of its sealed packaging.During physical / functional testing, the mount did not disengage from the implant as intended.The coob is non-verifiable as the condition of the implant / packaging when received by the customer is unknown / non-verifiable.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1260891.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 1260891 for similar events and one (1) other complaint was identified (b)(6).Review completed utilizing keywords: ¿does not disengage/release¿ 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 causes determined from the investigation are incorrect techniques used during implant placement - customer error.Therefore, based on the available information, and functional testing a device malfunction did occur.The reported event/coob was non-verifiable since the condition of the product/packaging when received by the customer was unknown / non-verifiable.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" 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: IMP, TSV, 4.7,10,MTX,MC,MG,HA
• 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: 19563543
• Report Number: 0002023141-2024-02038
• Device Sequence Number: 7501018
• Product Code: DZE
• UDI-Device Identifier: 00889024344143
• UDI-Public: (01)00889024344143(17)280325(10)1260891
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101880
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: Lay User/Patient
• Device Catalogue Number: TSVMWH10
• Device Lot Number: 1260891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• 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: 06/18/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2023
• 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: Male
• Patient Ethnicity: Non Hispanic