MAUDE Adverse Event Report: ZIMMER DENTAL 15 DEG TAPER 3.5P 3MM-4MM; DENTAL ABUTMENT

Model Number 15AT334

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Weight unknown / not provided.Fax number unknown / not provided.

Event Description

It was reported that the abutment did not seat to the implant.Doctor placed another abutment to the implant and finished the procedure.

Event Description

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

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).One 15 deg taper 3.5p 3mm-4mm (15at334) was returned for investigation.Visual inspection of the as returned product identified signs of wear from use about the abutment body, and some debris on the threads.Functional testing of the returned device notes that the abutment assembled and fully seated with a mating implant.No pre-existing conditions were noted on the per.The reported product was located on an unknown tooth site and was removed immediately.Review of appropriate documentation: documents reviewed: 4894 rev 6 - 08/19; adverse effects; page 4 dhr review was completed for the subject lot number 2020060512.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2020060512) for similar event 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 (component does not seat) or product (15at334).Therefore, based on the available information, device malfunction has not occurred and the reported event was unconfirmed.

Event Description

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

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 this event has been reassessed as not reportable, this malfunction is not likely to cause or contribute to a serious injury or death if it were to recur.The most likely outcome would be customer / patient inconvenience resulting in an additional dental appointment to refit the abutment.

• Brand Name: 15 DEG TAPER 3.5P 3MM-4MM
• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11102258
• MDR Text Key: 224601480
• Report Number: 0002023141-2020-02443
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00889024012059
• UDI-Public: (01)00889024012059(17)250629(10)2020060512(241)15AT334
• Combination Product (y/n): N
• PMA/PMN Number: K111853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15AT334
• Device Catalogue Number: 15AT334
• Device Lot Number: 2020060512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR