MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1MM,SBM,13; DENTAL IMPLANT

Model Number	IIIC41
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event.Please see associated report: 0002023141-2021-01859.Zimmer biomet complaint number (b)(4).A summary investigation has been completed for lack of primary stability events that do not allege a deficiency with the implant and identified that the reported event is likely due to biological factors which have an adverse effect on implant stability or is related to surgical technique and insertion torque.Due to a wide range of external (non-design/ non-manufacturing related), identifying a definitive root cause is generally not possible.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
It was reported that the implants at tooth sites #30 & #11 did not integrate due to lack of primary stability and were removed.The areas were grafted and the patient is returning for implant replacement at a later date.
Event or Problem Description
It was determined that the implant reported has an incorrect lot number associated with this product.During follow up, the customer was unaware of a separate lot number.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and corrected data.The following sections are being reported: b3: event description was updated.B4: date of this report was updated.D4: lot number and unique device identifier (udi) number updated to unknown.G6: type of report was updated.H2: type of follow up was updated.H4: device manufacture date updated to unknown h10: narrative/data was updated.It was determined that the tsv4b13 reported has an incorrect lot number associated with this product.

• Brand Name: IMP,TSV,4.1MM,SBM,13
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12204387
• Report Number: 0002023141-2021-01860
• Device Sequence Number: 14763494
• Product Code: DZE
• UDI-Device Identifier: 00844868005582
• UDI-Public: (01)00844868005582(17)240513(10)1228317
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072589
• 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,user faci
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2021

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: Health Professional
• Device Expiration Date: 05/13/2024
• Device Model Number: IIIC41
• Device Catalogue Number: TSV4B13
• Device Lot Number: 1228317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 07/31/2021
• 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
• Patient Age: 67 YR