MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7, 8, MTXF, MG, HA; DENTAL IMPLANT

Model Number	TSVTWH8
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Email address and fax number unknown / not provided.Additional pma/510(k) number ¿ k133339.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 migrated into the maxillary sinus and was removed.Symptoms as a result of the event: pain, inflammation tooth location unknown.
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: 4310.One imp, tsv, 4.7, 8, mtxf, mg, ha (tsvtwh8) implant was returned for investigation.Visual evaluation of the as returned product identified no apparent malfunction.Signs of use.The device could not be functionally tested for the reported failures (relocated to sinus) as it is medical event.However, measurements were taken using a caliper.Pre-existing patient condition noted on the per was parkinsons.The reported device was being placed on tooth #unk for about 7 months.X-ray or picture images were not provided.Therefore, the reported event could not be verified.Per the applicable ifu, under section warnings, it is stated that improper techniques can cause bone loss, patient injury, pain and implant failure.Dhr review was completed for the subject lot number 1230038.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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review by lot number (1230038) was performed for similar event (keyword category: perforated sinus, relocated to sinus, perforated sinus) and no other similar complaint was identified.November post market trending was reviewed and there were no actionable events or corrective actions for the reported events or product.A definitive root cause could not be identified.However, based on the investigation and risk file review, the most likely cause is customer error in surgical site preparation based on implant size.Therefore, based on the available information and dimensional analysis, device malfunction did not occur.Additionally, the reported event could not be verified since it was a medical condition and no x-ray or pictorial evidence was available.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: IMP, TSV, 4.7, 8, 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: 12360523
• Report Number: 0002023141-2021-02281
• Device Sequence Number: 17102327
• Product Code: DZE
• UDI-Device Identifier: 00889024344389
• UDI-Public: (01)00889024344389(17)241116(10)1230038(241)TSVTWH8
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 01/11/2022

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 Expiration Date: 11/16/2024
• Device Model Number: TSVTWH8
• Device Catalogue Number: TSVTWH8
• Device Lot Number: 1230038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• 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: 07/30/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2019
• 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