MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 5.7X6.5, 3MM; HEALING COLLAR

Model Number	HC563
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that after placing a 6 mm implant, clinician went to place the hc563 and it would not engage the implant.The procedure was able to be completed with another hc563 that they had at the office with no issues.Tooth #14.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
A heal collar 5.7x6.5, 3mm (hc563) was returned for investigation., visual inspection of the as returned product identified worn markings and damage around the threads due to usage.An unk zd implant was not returned.Since product has not been returned, visual/functional inspection could not be performed.The customer did not claim any issues with unk zd implant as a replacement hc563 engaged as normal.Procedure completed.No further investigation will be conducted for unk zd implant.Functional testing was performed for the returned product with an in-house stock device and did not seat as intended pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.Pictures or x-ray images were not provided.Appropriate documentation was provided.Dhr review was completed for the subject lot number (2019070130).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 was performed for the reported lot number (2019070130) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.The following sections have been updated: g7: checked "follow-up." h3: changed "no" to "yes.".

• Brand Name: HEAL COLLAR 5.7X6.5, 3MM
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10727942
• Report Number: 0002023141-2020-01766
• Device Sequence Number: 16925324
• Product Code: NHA
• UDI-Device Identifier: 00889024015111
• UDI-Public: (01)00889024015111(17)240703(10)2019070130(241)HC563
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 07/03/2024
• Device Model Number: HC563
• Device Catalogue Number: HC563
• Device Lot Number: 2019070130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 01/06/2021
• 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: 73 YR