MAUDE Adverse Event Report: ZIMMER DENTAL ABUT HEX-LOCK 3.5MM IMP 4 .5 FLARE; DENTAL ABUTMENT

Catalog Number	HLA3/4
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age at time of event unknown / not provided.A4: patient weight unknown / not provided.D4: additional device information unknown / not provided.D4: unique identifier (udi) number not available.D10: concomitant medical product and therapy dates: hla3/5 , abut hex-lock 3.5mm imp 5.5 flare, lot number: 62996364.E1: reporter phone:(b)(6).G4: premarket identification k013227.H4: device manufacturer date unknown / not provided.
Event or Problem Description
The doctor reports that the abutments do not have sufficient retention.The procedure was completed using another abutments.The patient did not suffer any negative impact on their health as a result of the event.The affected dental position are: #36 & #37.Bone type: unknown.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.It was reported that the abutments did not have sufficient retention at sites 36 and 37.The procedure was completed using other abutments.Bone density was unknown.Zimvie received one (1) hla3/4, (abut hex-lock 3.5mm imp 4.5 flare) for evaluation.Visual evaluation and a functional test was performed, there was signs of use was identified.The abutment and screw threaded into in-house implant as intended.Unable to confirm loosening with all the available information.Dhr review was completed for the subject lot number 2017071052.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 2017071052 for similar events and 2 other relevant complaint(s) were identified.Review completed utilizing keywords: dental : functional : loosening.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the abutment was not seated properly, improper screw placement.Therefore, based on the available information, a device malfunction did not occur.The screw threaded into in-house implant as intended.The reported event was non-verifiable with all the available information.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 HEX-LOCK 3.5MM IMP 4 .5 FLARE
• 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: 18491834
• Report Number: 0002023141-2024-00043
• Device Sequence Number: 6991942
• Product Code: DZE
• UDI-Device Identifier: 00889024015166
• UDI-Public: (01)00889024015166(17)220720(10)2017071052
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K011028
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/19/2022
• Device Catalogue Number: HLA3/4
• Device Lot Number: 2017071052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2023
• 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: 01/11/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT; DENTAL ABUTMENT
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic