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

Model Number HC345

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Weight unknown / not provided.

Event Description

It was indicated that the healing collar failed to be placed.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).One healing collar (hc345) was returned for investigation.Visual evaluation of the as returned product identified signs of wear due to usage around the threads.Functional testing was performed using an in-house implant.The device could not seat as normal on the implant.Pre-existing condition noted on the per was high bone density ¿ type i.Doctor was attempting to place the device on an unknown tooth location when the incident occurred.X-ray or picture images were not provided and no other information was provided.Dhr review for the lot (2019011477) 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 was performed for the lot (2019011477) for similar event and no other complaint was identified.Therefore, based on the available information, device malfunction has occurred and the reported event was confirmed.

Event Description

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

• Brand Name: HEAL COLLAR 3.5X4.5, 5MM
• Type of Device: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9715942
• MDR Text Key: 183090938
• Report Number: 0002023141-2020-00315
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00889024015005
• UDI-Public: (01)00889024015005(17)240128(10)2019011477(241)HC345
• Combination Product (y/n): N
• PMA/PMN Number: K111852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

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: Health Professional
• Device Expiration Date: 01/28/2024
• Device Model Number: HC345
• Device Catalogue Number: HC345
• Device Lot Number: 2019011477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 04/09/2020
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR