MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X4.5, 3MM; HEALING COLLAR

Model Number	HC343
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age and date of birth unknown / not provided.A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that healing color does not enter.After the tsv implant was placed, the doctor tried to apply a healing collar during the secondary operation, but it was reported that it did not work.The doctor tried hc343 and tried hc345.However, both did not enter.Both were new.The doctor entered with another hc, so it was completed.No health hazard.The doctor has doubts and wants a survey response of the actual product.
Additional Manufacturer Narrative
Zimvie received one (1) hc343, (heal collar 3.5x4.5, 3mm) for evaluation.Visual evaluation was performed, a damage threads identified resulting in failure to seat.Dhr review was completed for the subject lot number 2020091381.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 2020091381 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 rm-00057-haz, the most likely root cause determined from the investigation was healing abutment connection geometry is not designed correctly (including design tolerances) for implant connection.Therefore, based on the available information, a device malfunction did occur.The abutment had damage threads identified resulting in failure to seat.The reported event was 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.".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X4.5, 3MM
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 17037675
• Report Number: 0002023141-2023-01525
• Device Sequence Number: 17757162
• Product Code: NHA
• UDI-Device Identifier: 00889024014992
• UDI-Public: (01)00889024014992(17)250929(10)2020091381
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2023

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: Other
• Device Expiration Date: 09/29/2025
• Device Model Number: HC343
• Device Catalogue Number: HC343
• Device Lot Number: 2020091381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic