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

Model Number	HC455
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant was placed and the healing collar would not screw into implant.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified the first part of the threads were damaged.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.No pre-existing conditions were noted on the product experience report (per).The reported device was located on tooth # 14 (universal) and was not used.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.Complainant reported that the implant was placed and the healing collar would not screw into the implant.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.'.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 4.5X5.5, 5MM
• Common Device Name: HEALING 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: 13633038
• Report Number: 0002023141-2022-00533
• Device Sequence Number: 2213447
• Product Code: NHA
• UDI-Device Identifier: 00889024015074
• UDI-Public: (01)00889024015074(17)261018(10)2021100650
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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 Model Number: HC455
• Device Catalogue Number: HC455
• Device Lot Number: 2021100650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 08/07/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2021
• 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: 80 YR
• Patient Sex: Female