MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED IMPLANT 5 X 8.5MM; DENTAL IMPLANT

Model Number	NT585
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported device malfunction.When placing the implant doctor noticed two skips in the hand piece (40 nw).When checking and removing the mount doctor noticed that 3 of the hex threads were damaged.Implant was then manually removed due to the impossibility to handle the implant through its connection.Another implant was placed to complete the procedure.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite® tapered implant 5 x 8.5mm (nt585) with mount was returned for investigation.Visual evaluation of the as returned product identified damaged hex and worn platform.Implant external threads were somewhat damaged as well, likely from the retrieval process.Debris on the threads identified.Device history record (dhr) review was completed for the subject lot number 2017111210.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 by lot number (2017111210) was performed for similar events and no complaint about nonconforming products was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: OSSEOTITE TAPERED IMPLANT 5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11574002
• Report Number: 0001038806-2021-00489
• Device Sequence Number: 17195060
• Product Code: DZE
• UDI-Device Identifier: 00844868012108
• UDI-Public: (01)00844868012108(17)221124(10)2017111210
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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: 11/24/2022
• Device Model Number: NT585
• Device Catalogue Number: NT585
• Device Lot Number: 2017111210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR