MAUDE Adverse Event Report: ZIMMER DENTAL BALL ABUT 3.5 MM 6 MM CUF F; DENTAL ABUTMENT

Model Number	BAC6
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw part of the abutment fractured in the patient's mouth.The broken screw inside the implant couldn¿t be retrieved so doctor abandoned the implant and is placing one right beside.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Patient identifier is not provided / unknown.Patient age is not provided / unknown.Patient weight is not provided / unknown.Date of event is not provided / unknown.Tsvtb8, imp,tsv,3.7,8,mtx,mg, lot number 1244785.Therapy date unknown / not provided.Initial reporter¿s title is not provided / unknown.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The reported device was not returned for investigation.The reported event was non-verifiable with the information provided.Based on the evaluation, the device malfunction could not be verified.However, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported devices that could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or devices.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and likely conforming when it left zimvie.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot number was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.A definitive root cause could not be identified.No further investigation and no 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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimvie will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: BALL ABUT 3.5 MM 6 MM CUF F
• Common Device Name: DENTAL ABUTMENT
• 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: 16121847
• Report Number: 0002023141-2023-00090
• Device Sequence Number: 6382862
• Product Code: DZE
• UDI-Device Identifier: 00889024014183
• UDI-Public: (01)00889024014183(17)230710(10)2018070615
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K011028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2023

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: 07/10/2023
• Device Model Number: BAC6
• Device Catalogue Number: BAC6
• Device Lot Number: 2018070615
• Was Device Available for Evaluation?: No
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 05/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT, SEE NARRATIVE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose