MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.1, 10, MTXF, MG,HA; DENTAL IMPLANT

Model Number	TSVT4H10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Fax number and first/given name unknown / not provided.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant collar at tooth location #5 fractured during replacement.Customer was able to complete the procedure with another implant.
Event or Problem Description
During inspection, it was noted that the mount was fractured, and the implant showed minor signs of use but was not fractured as initially reported.Upon follow up, the customer reported that the mount fractured as the doctor was placing the implant.Because they were not sure if the implant collar was damaged or not, they decided against using the implant.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data, additional information and device evaluation.Correction: it was confirmed that the mount was fractured, and the implant showed minor signs of use but was not fractured as initially reported.H6: investigation type codes were added: 3331, 4109, 4110 and 4111.H6: investigation findings code was added: 3252.H6: investigation conclusions codes were added: 4307.H10: narrative/data was updated.One (1) imp, tsv, 4.1, 10, mtxf, mg,ha (tsvt4h10) was returned for investigation.Visual evaluation of the as returned implant identified that the mount fractured at hexed area.Based on the evaluation, device malfunction has occurred.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review for the lot (1251927) revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Complaint history review was performed for the reported lot number (1251927) for a similar event (complaint category keywords: fracture: mount) and no other complaint was identified.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Therefore, the reported event could not be recreated.A definitive root cause could not be determined.However, based on the investigation, risk review and ifu, the most likely cause determined from the investigation is: incompatibility with consumables/accessories/other devices.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: IMP, TSV, 4.1, 10, MTXF, 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14454660
• Report Number: 0002023141-2022-01245
• Device Sequence Number: 6569481
• Product Code: DZE
• UDI-Device Identifier: 00889024344198
• UDI-Public: (01)00889024344198(17)270309(10)1251927
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K133339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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: Health Professional
• Device Model Number: TSVT4H10
• Device Catalogue Number: TSVT4H10
• Device Lot Number: 1251927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown