MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Model Number	NT3211
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age at time of the event unknown / not provided.Gender unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Reporter name and address unknown / not provided.
Event or Problem Description
Doctor reported that the cover screw could not be disengaged from the implant.The procedure was finished using another implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite® tapered implant 3.25 x 11.5mm (nt3211) was returned for investigation and evaluated.Visual evaluation of the as returned product identified signs of use and removal via blood, bone and damage to the implant.The implant and cover screw were received separated and could not be functionally tested towards the reported does not disengage event due to the nature of the device & event.No damage was identified with returned cover screw.Damage observed on returned implant due to removal is not considered a malfunction or failure of the device.Zimmer biomet is not responsible for any damage caused by the clinician¿s removal of the device.Device history record (dhr) review was completed for the subject lot number (2018091485).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, were 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 (2018091485) for similar events and no other complaint was identified (complaint category keyword(s): does not disengage/release).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable as the implant and cover screw were received separated and could not be functionally tested towards the reported does not disengage event due to the nature of the device & event.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE TAPERED IMPLANT 3.25 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12335304
• Report Number: 0001038806-2021-01548
• Device Sequence Number: 19583676
• Product Code: DZE
• UDI-Device Identifier: 00844868011972
• UDI-Public: (01)00844868011972(17)231002(10)2018091485
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/05/2021

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: 10/02/2023
• Device Model Number: NT3211
• Device Catalogue Number: NT3211
• Device Lot Number: 2018091485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1