MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TM 3.7MM MTX FULL,13M; DENTAL IMPLANT

Model Number	TMTB13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Doctor's office reported extreme pain that started 3 weeks after placement.Implant removed.Patient to return for additional appointment.Symptoms as a result of the event: pain.Tooth location not reported.
Additional Manufacturer Narrative
One imp, tm 3.7mm mtx full,13m (tmtb13) was returned for investigation.Visual evaluation of the as returned product identified signs of usage and what appears to be bone tissue/debris attached to the implant external threads and inside the drive feature.No significant damage was identified.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing condition and the tooth location were unknown due to limited information provided by the customer.However, the device was used for approximately 3 weeks.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 1227703.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.Sterilization record (op#230) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review by lot number (1227703) was performed for similar events and no other similar complaint was identified.Based on the available information, device malfunction did not occur and the reported event was non-verifiable.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,TM 3.7MM MTX FULL,13M
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11517446
• Report Number: 0002023141-2021-00671
• Device Sequence Number: 11745443
• Product Code: DZE
• UDI-Device Identifier: 00889024019010
• UDI-Public: (01)00889024019010(17)240521(10)1227703
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 05/21/2024
• Device Model Number: TMTB13
• Device Catalogue Number: TMTB13
• Device Lot Number: 1227703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention