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

Model Number	HC455
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: first name unknown / not provided.
Event or Problem Description
It was reported that doctor confirmed he finished the procedure with another healing abutment.Hc455 did not fit with the implant¿s thread, implant itself seemed okay and was not removed.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).Zimvie received one (1) hc455, (heal collar 4.5x5.5, 5mm) for evaluation.Zimvie did not receive one (1) unknown zimmer implant.Visual evaluation and a functional test was performed, there was signs of use with some discoloration to the threads.The healing collar engaged and disengaged with an in-house implant.This complaint refers to the hc455.Dhr review was completed for the subject lot number 2022020019.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 2022020019 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : fit : does not seat¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per (b)(4), the most likely root cause determined from the investigation was missing or confusing instructions for use or the torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did not occur.The abutment engaged and disengaged with an in-house implant.The reported event was not confirmed.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.The following sections have been updated: g6: checked "follow-up." h3: changed "no" to "yes.".

• Brand Name: HEAL COLLAR 4.5X5.5, 5MM
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): HEAL COLLAR 4.5X5.5, 5MM; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 17275178
• Report Number: 0002023141-2023-01810
• Device Sequence Number: 11633063
• Product Code: NHA
• UDI-Device Identifier: 00889024015074
• UDI-Public: (01)00889024015074(17)270203(10)2022020019
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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 Model Number: HC455
• Device Catalogue Number: HC455
• Device Lot Number: 2022020019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/06/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic