MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X5.5, 3MM; DENTAL ABUTMENT

Model Number	HC353
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Last name unknown / not provided.
Event or Problem Description
It was reported that the healing abutment would not seat in the implant.They were able to complete the procedure with another healing abutment.Tooth location not reported.
Additional Manufacturer Narrative
One heal collar 3.5x5.5, 3mm (hc353) was returned for investigation.Visual evaluation of the as returned product identified no apparent malfunction.Functional testing was performed with in-house implant.The healing collar was able to seat into the implant as normal.No pre-existing condition was noted in the per.The device was 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 (2020110052) 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.Complaint history review was performed for the reported lot number (2020110052) for similar events and no other complaint was identified.June post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Based on the available information, device malfunction did not occur and the reported event was unconfirmed.The following sections have been updated: g6: checked "follow-up." h2: checked follow-up type.H3: changed "no" to "yes.".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X5.5, 3MM
• Common Device Name: DENTAL ABUTMENT
• 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: 13791314
• Report Number: 0002023141-2022-00665
• Device Sequence Number: 16566270
• Product Code: NHA
• UDI-Device Identifier: 00889024015029
• UDI-Public: (01)00889024015029(17)251105(10)2020110052
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/31/2022

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: 11/05/2025
• Device Model Number: HC353
• Device Catalogue Number: HC353
• Device Lot Number: 2020110052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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