MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X5.5, 7MM; DENTAL HEALING COLLAR

Catalog Number HC457

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported that the healing cap threads do not engage the implant.The implant remains implanted.

Manufacturer Narrative

One (1) heal collar 4.5x5.5, 7mm (hc457) was returned for investigation.Visual evaluation of the as returned product identified signs of use.Functional testing to recreate the reported event; verified the healing cap threads engaged properly with an in-house implant.No malfunctions detected that could lead to reported event.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on an unknown tooth site and was used.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (63757432).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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (63757432) for similar events and no other complaint was identified.(b)(6) post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not seat) or product (hc457).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, and functional testing device malfunction did not occur, and the reported event was non-verifiable without return of all items involved.

Event Description

No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 4.5X5.5, 7MM
• Type of Device: DENTAL HEALING COLLAR
• 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: 15993142
• MDR Text Key: 306256336
• Report Number: 0002023141-2022-03145
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 0088902401508
• UDI-Public: (01)0088902401508(17)220731(10)63757432
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K111852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: HC457
• Device Lot Number: 63757432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose