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

Model Number	HC345
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/20/2020
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.Patient sex unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that the abutment could not be screwed in.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One healing collar (hc345) was returned for investigation.Visual evaluation of the as returned product identified that the threads were severely damaged.Functional testing was performed using applicable in-house implant; the implant was not able to seat the healing collars as the thread were severely damaged.No pre-existing conditions were noted on the per.The device was being placed on an unknown tooth location when the incident occur.X-ray or picture images were not provided and no other information was provided.Review of appropriate documentation: documents reviewed: instructions for use ¿ zimmer dental healing collars, healing screws, surgical cover screws, temporary gingival cuffs, and temporary abutments for use with zimmer dental implant systems, ifu9658 rev 2-10/19.Information identified: indications and warnings.Per the applicable ifu, it is stated that 'surgical and restorative techniques required to place dental implants are highly specialized and complex procedures.Practitioners should attend courses of study to familiarize themselves with implantology techniques.Improper technique can cause device failure.' dhr review for the lot (2020070839) 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 lot (2020070839) for similar events and no other complaint was identified.January post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Therefore, based on the available information and functional testing, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X4.5, 5MM
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11108769
• Report Number: 0002023141-2021-00019
• Device Sequence Number: 4050992
• Product Code: NHA
• UDI-Device Identifier: 00889024015005
• UDI-Public: (01)00889024015005(17)250721(10)2020070839(241)HC345
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 07/21/2025
• Device Model Number: HC345
• Device Catalogue Number: HC345
• Device Lot Number: 2020070839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1