MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X5.5, 5MM; DENTAL HEALING ABUMTNET

Model Number	HC355
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that the healing collar cannot be screwed into the implant thread.Doctor was able to finished the procedure using another healing collar.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One heal collar 3.5x5.5, 5mm was returned for investigation.Visual evaluation of the as returned product identified thread damage.Functional testing was performed with in-house mating implant.The device could not seat ¿ could not be threaded into the implant.No pre-existing conditions were noted on the per.The reported device was intended for an unknown tooth location.Review of appropriate documentation: documents reviewed: -instructions for use ¿ zimmer dental healing collars, healing screws, surgical cover screws, temporary gingival cuffs, and temporary abutments for use with zimmer dental implant systems, ifu9658 rev 2-10/19.Information identified: indications and warnings per the applicable ifu, improper techniques and overloading may lead to device failure.Dhr review: dhr review for the lot (2021011405) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2021011405) for similar events (complaint category keywords: fit: does not seat) and no other complaint was identified.Post market trending review: november post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X5.5, 5MM
• Common Device Name: DENTAL HEALING ABUMTNET
• 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: 12681118
• Report Number: 0002023141-2021-02969
• Device Sequence Number: 1232103
• Product Code: NHA
• UDI-Device Identifier: 00889024015036
• UDI-Public: (01)00889024015036(17)260208(10)2021011405
• 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): 01/26/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2026
• Device Model Number: HC355
• Device Catalogue Number: HC355
• Device Lot Number: 2021011405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• 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: 09/29/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female