MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL ABUTMENT

Device Problem Fracture (1260)

Patient Problem Discomfort (2330)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Udi not available.Pma/510(k) number not available.

Event Description

It was reported that part of the crown was stucked in the implant.Impossible to remove loose crown.The hex of this crown has broken off and was stucked in the implant.They could not remove it.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).One implant (tsvwb8) associated item (hc453) and unknown zimmer abutment were returned for investigation.There were no allegations against the associated item (hc453).Therefore, this investigation addressed only the implant, abutment and reported events.Visual evaluation of the as returned implant identified fragment of abutment hex in the drive feature.There was bone residue around the external threads due to usage.Additionally, the implant platform was damaged possibly during removal attempts.Damage observed on returned implants due to trephine removal is not considered a malfunction or failure of the device.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing could not be performed due to the nature of the devices and events.Pre-existing condition noted on the per was 'smoker'.The devices had been placed on tooth #26 (fdi) for approximately 2 ½ years.X-ray or picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: document reviewed: instructions for use ¿ prosthetics for zimmer dental implant systems ¿ ifu4894 rev 6 ¿ 08/19.Instructions for use - tapered screw-vent and trabecular metal implants, ifu4869 rev 9-10/19.Information identified: warnings, precautions and breakage.Per the applicable ifu, it is stated that improper techniques as well as severe bruxism, clenching, and overloading, may cause component fracture.Dhr review: dhr review for the lot (64082191) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.However, dhr could not be reviewed for the unknown abutment since the lot/item number was unknown.Complaint history review: complaint history review was performed for the reported lot number (64082191) for similar events (complaint category keywords: does not disengage and fracture) and no other complaint was identified.However, complaint history could not be reviewed for the unknown abutment since the lot/item number was unknown.Post market trending review: september post market trending was reviewed and there were no actionable events or corrective actions for the reported events or products.Therefore, based on the available information, device malfunction did occur, and the reported events were confirmed.

• Type of Device: 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: 14592535
• MDR Text Key: 293287662
• Report Number: 0002023141-2022-01379
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male