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

Model Number	HC335
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Date of event unknown / not provided.Last name unknown / not provided.
Event or Problem Description
It was reported that clinician was unable to seat a healing abutment during a procedure.They were able to complete the procedure with another healing abutment.They believe that the abutment threads may have been damaged.The rep did not have information for the implant.Tooth location not reported.
Additional Manufacturer Narrative
One heal collar 3.5x3.5, 5mm (hc335) and one unknown zimmer implant were reported but not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use, risk files and other available information.Functional testing could not be performed due to the nature of the devices and event.No pre-existing condition was noted in the per.The devices were intended for an unknown tooth location.X-ray or picture images were not provided and no other information was provided.Appropriate documentation was reviewed.Dhr review for the lot (2021020356) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.However, dhr review could not be conducted for the unknown zimmer implant since the lot number was unknown.Complaint history review was performed for the reported lot number (2021020356) for similar events and no other complaint was identified.However, complaint history could not be reviewed for the unknown zimmer implant since the lot/item number was unknown.Based on the available information, device malfunction and the reported event could not be verified.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X3.5, 5MM
• Common Device Name: DENTAL 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: 12625770
• Report Number: 0002023141-2021-02878
• Device Sequence Number: 5997123
• Product Code: NHA
• UDI-Device Identifier: 00889024014985
• UDI-Public: (01)00889024014985(17)260207(10)2021020356
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 04/21/2022

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: 02/07/2026
• Device Model Number: HC335
• Device Catalogue Number: HC335
• Device Lot Number: 2021020356
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2021
• 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 Sex: Prefer Not To Disclose