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

Model Number	HC343
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported that the healing abutment did not screw properly to the implant.Another healing abutment was placed.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One healing collar (hc343) was returned for investigation.Visual evaluation of the as returned product identified minor signs of wear due to usage.The device had no apparent malfunction.Functional testing was performed using applicable in-house implant; the implant was able to seat the healing collar as normal.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.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 (pages 1 & 2).Per the applicable ifu, under section arnings, it is stated, 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 (63761829) 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 (63761829) for similar events and no other complaint was identified.September post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information and functional testing, device malfunction did not occur and the reported event was unconfirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X4.5, 3MM
• Common Device Name: DENTAL HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10540328
• Report Number: 0002023141-2020-01434
• Device Sequence Number: 10839001
• Product Code: NHA
• UDI-Device Identifier: 00889024014992
• UDI-Public: (01)00889024014992(17)220831(10)63761829(241)HC343
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 08/31/2022
• Device Model Number: HC343
• Device Catalogue Number: HC343
• Device Lot Number: 63761829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 57 YR