MAUDE Adverse Event Report: ZIMMER DENTAL ABUT CONTOUR 3.5X4.5 2MM CUFF; DENTAL SCREW

Catalog Number	ZOA342S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in a follow up with the patient, it was noted that the abutment was loose to the point that the screws were dislodged and broken, preventing forceful locking and resulting in failure of the implant, therefore removing it.Tooth site #16 (fdi).
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).A4: weight unknown / not provided.D1: brand name unknown / not provided.D4: catalog and lot number unknown / not provided d10: tsvb16, impl tapered scr-v sbm 3.7mm 3.5mm 16mm/lot number-63718877 g4: pma/510(k) number not available.It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: d2-product code was updated from dze to nha.The following sections are being reported: b4: date of this report was updated.D1: brand name was updated.D4: catalog number, lot number, expiration date and unique device identifier (udi) number were updated.G3: date received by manufacturer was updated.G4: pma/510(k) number was updated.G6: type of report was updated.H2: type of follow up was updated.H4: device manufacture date was updated.H10: narrative/data was updated.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: product availability updated to no.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111, 4114 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4315.H10: narrative/data was updated.Zimvie did not receive the reported abutment for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 63850241.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 63850241 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was abutment screw is not torqued to specification and torque applied during placement/ seating exceeds recommended value.Therefore, based on the available information, device malfunction could not be verified.Without device receipt, the reported event is non-verifiable.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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: ABUT CONTOUR 3.5X4.5 2MM CUFF
• Common Device Name: DENTAL SCREW
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19415304
• Report Number: 0002023141-2024-01751
• Device Sequence Number: 16947300
• Product Code: NHA
• UDI-Device Identifier: 00889024020740
• UDI-Public: (01)00889024020740(17)221031(10)63850241
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052600
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2022
• Device Catalogue Number: ZOA342S
• Device Lot Number: 63850241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 06/07/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT-SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic