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

Model Number	HC343
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Patient gender: unknown / not provided.Patient weight: unknown / not provided.Reporter last name: unknown / not provided.Pma/510(k) number: unknown / not provided.Device manufacturer date: unknown / not provided.
Event or Problem Description
It was reported that the implant in site 72 was removed due to healing cap would not disengage implant.Procedure was completed using another device.Patient impact: noted pain at site.No further impact site grafted: allograft placed.Medical history: no medical history reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The following sections have been updated: b4: date of this report d1: brand name d4: catalog number d4: lot/serial # d4: device expiration date d4: device udi number g3: date received by manufacturer g4: pma/510(k) number g6: checked "follow-up" h2: checked follow-up type h4: device manufacturer date h10: added manufacturer narrative.
Additional Manufacturer Narrative
One (1) imp,tsv,3.7,11.5,mtx,mg (tsvtb11) and one (1) heal collar 3.5x4.5, 3mm (hc343) were returned for investigation.Visual evaluation of the as returned products identified signs of use.Functional testing was performed to disengage the devices.They were not able to disengage.A pre-existing condition was not noted on the per form.The bone density was low density (type iii).The reported device was located on tooth location # 7 (unknown dental notation system) and was used for approximately four (4) months.The customer did not provide any images for the reported event.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 1251896.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 1251896 for similar events and no other complaint was identified.Dhr review was completed for the subject lot number 2021110633.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 2021110633 for similar events and no other complaint was identified.March post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, the reported malfunction did occur and the event was confirmed.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: 16240034
• Report Number: 0002023141-2023-00286
• Device Sequence Number: 6523177
• Product Code: DZE
• UDI-Device Identifier: 00889024014992
• UDI-Public: (01)00889024014992(17)261116(10)2021110633
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2023

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: HC343
• Device Catalogue Number: HC343
• Device Lot Number: 2021110633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/31/2023; 05/03/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/08/2023; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Prefer Not To Disclose