MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,3.7MM,16M; DENTAL IMPLANT

Model Number	TSVMB16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Sensitivity of Teeth (2427)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Date of event 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
The doctor advised of bone/jaw fracture at implant area #15.Patent advised that the bone/ fracture is a result of chewing/torque of dental implant.Patient agrees to surgical extraction of the implant.Symptoms as a result of the event: sensitivity and pain.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: investigation type codes were added: 3331, 4109, 4110, and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67.One imp, tsv, mcol mg,3.7mm,16m (tsvmb16) was returned for investigation.Visual evaluation of the as returned product identified signs of use but no apparent signs of malfunction.Functional testing could not be performed for the reported event (bone fracture) as it is a medical condition.Based on the evaluation, device malfunction has not occurred.Additionally, 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 actionable trends or corrective actions for the reported event or device.Zimmer biomet 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 zimmer biomet.Dhr review for the lot (1252052) 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 (1252052) for similar events (complaint category keywords: medical: bone fracture) and no other complaint was identified.Functional testing could not be performed for the reported event (bone fracture) as it is a medical condition.Therefore, the reported event could not be recreated.A definitive root cause could not be determined.Based on the investigation, risk review and ifu, the probable causes for the reported event are clinician error (improper surgical procedure) and patient factors (osteopenia).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.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: IMP,TSV,MCOL MG,3.7MM,16M
• 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: 14799911
• Report Number: 0002023141-2022-01615
• Device Sequence Number: 5058433
• Product Code: DZE
• UDI-Device Identifier: 00889024019751
• UDI-Public: (01)00889024019751(17)270209(10)1252052
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K111889
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TSVMB16
• Device Catalogue Number: TSVMB16
• Device Lot Number: 1252052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 77 KG