MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL ABUTMENT

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.Date of the event unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Additional device information unknown / not provided.Reporter name and address were not provided.Premarket identification pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.Since the lot number and device will not be returned , identifying a definitive root cause will not be possible.Should additional information be received which indicated that the device may have caused or contributed to the event, an additional report would be submitted.

Event Description

It was reported that patient was not able to get a permanent prosthetic solution to the implants as the provisionalisation was constantly falling out.Tooth locations 14, 16, 24, 25, 34, 36, 37, 46 and 47.Patient spend a long period of time with no teeth before the implantation, after a successful implantation and during process for prosthetics patient complaints of pain in the jaw and discomfort in chewing.

Event Description

Abutments used are zimmer, doctor is not able to provide product information.Clinician claims that the abutments did not fall out but the crowns de-cemented because they were fixed with temporary cement.Implants were placed simultaneously on the upper and lower jaw, during the engraftment process, there were no problem.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4) the following sections have been updated:  b4: date of this report  b5: describe event or problem g3: date received by manufacturer  g6: type of report h1: type of reportable event  h2: follow up type  h10: additional narrative based on the available information provided, no serious injury or adverse event has been reported to this event.Also, the abutments did not loosen but the temporary cemented structure kept coming off, there is no allegation against our product.There is no indication that this device has caused or contributed to the event; as a result, this event has been reassessed as not reportable. .

• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11632874
• MDR Text Key: 246668103
• Report Number: 0002023141-2021-00880
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1