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

Model Number	HC455
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that clinician was not able to place healing cap in the implant at tooth location 30.The patient came in for implant placement on (b)(6) 2019, and after a tsvvwb11 implant was placed, the healing cap could not be screwed, the product was not fitted to the implant completely and was slightly shaken, and an abutment in the same model was replaced and could be used normally.No injury or delay.
Additional Manufacturer Narrative
A heal collar 4.5x5.5, 5mm (hc455) was not returned.Since product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available information.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is same day.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (63671608).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 (63671608) for similar event and no other complaint was identified.Based on the available information, device could not be verified and the reported event was non-verifiable.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
A heal collar 4.5x5.5, 5mm (hc455) was misplaced/lost in-house.Therefore, the product has not been physically inspected and visual/functional evaluation could not be performed.The investigation has been performed based on the available device information.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is same day.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (63671608).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 (63671608) for similar event and no other complaint was identified.Based on the available information, device could not be verified and the reported event was non-verifiable.The following sections have been updated: g7: checked "follow-up." h3: changed "yes" to "no." h3 other text : was misplaced/lost in-house.
Additional Manufacturer Narrative
A heal collar 4.5x5.5, 5mm (hc455) was returned for investigation, see attached images a186 ¿ a188 in the complaint.Visual inspection of the as returned product identified worn markings due to usage however no damage.Functional testing was performed for the returned product with an in-house stock device and seated as intended.No malfunction identified.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is same day.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (63671608).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 (63671608) for similar event and no other complaint was identified.Based on the available information, device malfunction did not occur the reported event was unconfirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 4.5X5.5, 5MM
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10343980
• Report Number: 0002023141-2020-01134
• Device Sequence Number: 19047466
• Product Code: NHA
• UDI-Device Identifier: 00889024015074
• UDI-Public: (01)00889024015074(17)220430(10)63671608(241)HC455
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/27/2021

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: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: HC455
• Device Catalogue Number: HC455
• Device Lot Number: 63671608
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 10/20/2020; 01/06/2021; 01/25/2021
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 10/22/2020; 01/06/2021; 01/27/2021
• 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: 37 YR