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

Model Number	HC345
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the restoring doctor was not able to remove the healing collar and the implant moved.He removed implant and still was not initially able to remove the healing collar from the removed implant.Eventually he was able to separate.Tooth location not reported.
Event or Problem Description
Dec 10 2020 - per received with additional event information.Implant was torqued past 20 ncm.Could not remove abutment and then implant became 2 weak after 5 months of osseointegration.Implant was then removed with abutment and using hemostat, abutment was eventually removed.
Additional Manufacturer Narrative
One tapered screw-vent implant (tsvtb11), one healing collar (hc345), mount and screw were returned for investigation.Visual evaluation of the as returned products identified signs of wear and bone/blood residue around the external and internal threads of the implant due to usage.The healing collar head and upper threads of the implant appear to be damaged/scratched possibly during removal.Functional testing was performed.Healing collar and mount engaged and disengaged implant as normal.No pre-existing conditions were noted on the per.The implant had been placed on tooth # 7 (unknown notation system) for approximately 5 months.X-ray and picture images were not provided.Appropriate documentation was reviewed.Dhr review for the lot 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.Complaint history review was performed for the lot for similar events and no other complaints about nonconforming events were identified.Therefore, based on the available information and functional testing, device malfunction did not occur and the reported event was unconfirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X4.5, 5MM
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11026751
• Report Number: 0002023141-2020-02310
• Device Sequence Number: 13620155
• Product Code: NHA
• UDI-Device Identifier: 00889024015005
• UDI-Public: (01)00889024015005(17)250224(10)2020021411(241)HC345
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2021

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: 02/24/2025
• Device Model Number: HC345
• Device Catalogue Number: HC345
• Device Lot Number: 2020021411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 12/10/2020; 03/16/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/08/2021; 03/18/2021
• 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: 71 YR