MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X6.5, 5MM; HEALING COLLAR

Catalog Number	HC465
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that the implant & screw at tooth site #19 fractured and was removed.(b)(6) 2024 pt to retrieve fractured implant screw found by dds.Reports tooth became loose late last week, was scheduled to come in for a check with dds and tooth fell off completely before her appointment.Dds noted restorative screw fractured and referred for retrieval.Exam: hypermobile implant restorative screw shaft.Pax demonstrates retained portion of abutment stem and screw shaft present.Suspicious vertical lucency near fixture crest.Discussed screw shaft removal and abutment stem removal, inspect implant.Consent, topical 1 /2 carp 2% lido w/epi excised gingival overgrowth, hemastate to reverse the screw shaft and retrieve, scaler to free and remove the abutment fragment.Visual inspection for crack under microscope with our endodontist (photo in chart), crack noted in fixture crest.Healing abutment placed advised patient on returning for implant removal and bone graft for implant replacement rtc for implant removal and bg with dds.Symptoms as a result of the event: discomfort.
Additional Manufacturer Narrative
Zimvie did not receive one (1) hc465, (heal collar 4.5x6.5, 5mm) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 2018051634.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2018051634 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : fracture : abutment¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz, the most likely root cause determined from the investigation was patient factors.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported event is non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 4.5X6.5, 5MM
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 21593703
• Report Number: 0002023141-2025-00648
• Device Sequence Number: 15536575
• Product Code: NHA
• UDI-Device Identifier: 00889024015104
• UDI-Public: (01)00889024015104(17)230522(10)2018051634
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111852
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/22/2023
• Device Catalogue Number: HC465
• Device Lot Number: 2018051634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic