MAUDE Adverse Event Report: ZIMMER DENTAL ABUT TAPERED ONE-PIECE SCR-V 3.5MM 3MM; DENTAL ABUTMENT

Catalog Number	TAC3
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the abutment got stuck into the osteointegrated implant, leading to implant removal.Pain as a consequence of the event.Xenograft graft performed.
Additional Manufacturer Narrative
Zimmer biomet complaint number(b)(4).A4: patient weight unknown / not provided.E1: email address unknown / not provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) tsvb10, (impl tapered scr-v sbm 3.7mm 3.5mm 10mm) and one (1) tac3 (abut tapered one-piece scr-v 3.5mm 3mm) for evaluation.Visual evaluation and a functional test was performed, there was bone debris on the external threads and markings from removal.The abutment and implant wouldn¿t disengage from each other.This complaint refers to the tac3.Device history record (dhr) review was completed for the subject lot number 2022101167.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022101167 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : does not disengage/release.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was excessive loading on abutment/implant assembly.Therefore, based on the available information, a device malfunction did occur.The abutment would not disengage from the implant.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: ABUT TAPERED ONE-PIECE SCR-V 3.5MM 3MM
• 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 ; 5619713230
• MDR Report Key: 17610899
• Report Number: 0002023141-2023-02346
• Device Sequence Number: 7420761
• Product Code: DZE
• UDI-Device Identifier: 00889024018426
• UDI-Public: (01)00889024018426(17)271028(10)2022101167
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011028
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: TAC3
• Device Lot Number: 2022101167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TSVB10
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic