MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X4.5, 5MM; DENTAL ABUTMENT

Model Number	HC345
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Doctor reports that it was unable to screw the healing collar during the implant placement.He has finished the procedure placing another healing collar and the implant is fine.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.One heal collar 3.5x4.5, 5mm (hc345) was returned for investigation.Visual evaluation of the as returned products identified some signs of use and but no apparent malfunction identified.Device history record (dhr) review was completed for the subject lot number 2020070836.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review by lot number (2020070836) was performed for similar events and no other similar complaint was identified.Therefore, based on the available information, device malfunction did not occur and the reported event was unconfirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X4.5, 5MM
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11527188
• Report Number: 0002023141-2021-00695
• Device Sequence Number: 20170898
• Product Code: NHA
• UDI-Device Identifier: 00889024015005
• UDI-Public: (01)00889024015005(17)250721(10)2020070836
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: Health Professional
• Device Expiration Date: 07/21/2025
• Device Model Number: HC345
• Device Catalogue Number: HC345
• Device Lot Number: 2020070836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR