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

Model Number	HC343
Medical Device Problem Code	Fracture (1260)
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).Weight unknown / not provided.Date of event unknown / not provided.Dental implant: tsvtb10, imp,tsv,3.7,10,mtx,mg, lot# 63350269.Therapy date: unknown / not provided.Email address unknown / not provided.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the healing abutment on tooth site #30, fractured off into the implant.
Event or Problem Description
No additional event information received at this time of this report.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event.Please see associated report: (b)(4).The this report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were updated: 3331, 4109, 4110, 4111.H6: investigation findings code was updated: 3252.H6: investigation conclusion code was updated: 4307.H10: narrative/data was updated.(1) heal collar 3.5x4.5, 3mm (hc343) was returned for investigation.Visual evaluation of the as returned products identified that the healing collar had signs of use.The healing collar was identified broken inside implant.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Based on the evaluation, the device malfunction has occurred.However, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported device that could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and likely conforming when it left zimmer biomet.Dhr review for the lot 63419207 revealed no deviations nor non-conformances which could have caused or contributed to the reported events.Complaint history review was performed for the reported lot number for 63419207 similar events and no other complaint was identified.The reported event could not be recreated due to the nature of the dental device and event (fractures).The complaint is related to the functional performance of the device.A definitive root cause could not be identified.However, based on the investigation, risk review and ifu, the most likely causes determined from the investigation are parafunctional habits of the patient over the implantation period of 5 years and 5 months.No further investigation and no immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: HEAL COLLAR 3.5X4.5, 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: 16396977
• Report Number: 0002023141-2023-00572
• Device Sequence Number: 5685875
• Product Code: NHA
• UDI-Device Identifier: 00889024014992
• UDI-Public: (01)00889024014992(17)210630(10)63419207
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: HC343
• Device Catalogue Number: HC343
• Device Lot Number: 63419207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT:
• Patient Age: 59 YR
• Patient Sex: Male