MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X3.5, 3MM; HEALING COLLAR

Model Number	HC333
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that healing cap screw was broken and a portion of the screw was left in the implant at site number 4.Attempted to remove screw piece multiple times with no success, delay in restoring the implant.Patient will need to return to remove the fragment an restore implant.Grafting placed prior to placement.
Additional Manufacturer Narrative
The heal collar 3.5x3.5, 3mm (hc333) and imp,tsv,3.7,8,mtx,mg (tsvtb8) were not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the per.The reported product was located on tooth # 4 (universal) and used for approximately 8 months.The reported event could not be recreated due to the nature of the dental device and event (fracture).The customer has not provided additional pictures or x-ray images of the product.Appropriate documentation was reviewed.Dhr review was completed for the subject lot numbers 63786445 & 1226102.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 numbers (63786445 & 1226102) for similar event and no other complaint was identified.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.The following sections have been updated: b4: date of this report.G4: date received by manufacturer.G7: checked "follow-up".H2: checked follow-up type.H3: changed "yes" to "no".H6: entered evaluation codes.H10: added manufacturer narrative h3 other text : device not returned.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X3.5, 3MM
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10201654
• Report Number: 0002023141-2020-00949
• Device Sequence Number: 16775756
• Product Code: NHA
• UDI-Device Identifier: 00889024014978
• UDI-Public: (01)00889024014978(17)220930(10)63786445(241)HC333
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: HC333
• Device Catalogue Number: HC333
• Device Lot Number: 63786445
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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: 64 YR