MAUDE Adverse Event Report: ZIMMER DENTAL ABUT HEX-LOCK 5.7MM IMP 6 .5 FLARE; DENTAL ABUTMENT

Model Number	HLA5/6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient came in with loose crown at tooth #18.Could not get crown off.Crown was super loose and rotating completely.When removed, abutment came loose with crown.Healing abutment was put back on.The crown still cemented to abutment.The abutment screw loosened came out.Loosening was discovered because it was not very little loose, and patient did not want hole drilled through crown.When they came back the abutment was completely loose and came out easily.Removed and placed with healing abutment.Location unknown.
Additional Manufacturer Narrative
Zimvie complaint number(b)(4).Patient weight unknown / not provided.Pma/510(k): k013227.
Additional Manufacturer Narrative
Zimvie did not receive one (1) hla5/6, (abut hex-lock 5.7mm imp 6.5 flare) 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).This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2021040372.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 2021040372 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : loosening the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-002p3, the most likely root cause determined from the investigation was screw/product not torqued to specification.Therefore, based on the available information, a 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.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.The following sections have been updated:.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ABUT HEX-LOCK 5.7MM IMP 6 .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 ; 5617766700
• MDR Report Key: 16956248
• Report Number: 0002023141-2023-01381
• Device Sequence Number: 17010913
• Product Code: NHA
• UDI-Device Identifier: 00889024015241
• UDI-Public: (01)00889024015241(17)260415(10)2021040372
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: Other
• Device Expiration Date: 04/15/2026
• Device Model Number: HLA5/6
• Device Catalogue Number: HLA5/6
• Device Lot Number: 2021040372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2021
• 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
• Patient Age: 68 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic