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

Model Number	OSS585
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant and the mount are threaded and it was impossible to separate them.The doctor confirms that the procedure was not completed with another implant and that the patient did not suffer any impact on his health.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One implant was returned for investigation.Visual evaluation of the as returned product identified signs of use and some scratches on the threads.Devices could not be disengaged.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on tooth # 15 (fdi) and was used for one day.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev i - 2022/04/01 information identified: warnings and precautions.Dhr review : dhr review was completed for the subject lot number (2018070999).It was confirmed that all operations and inspections were executed as per applicable procedures.No deviations or non-conformance's, which could have caused or contributed to the reported event were noted as part of the dhr.Complaint history review: complaint history review was performed for the reported lot number (2018070999) for similar events and no other complaint was identified.Review completed utilizing keywords: 'does not disengage/release' post market trending review: april post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product (oss585).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: OSSEOTITE® IMPLANT 5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13024952
• Report Number: 0001038806-2021-02388
• Device Sequence Number: 14683896
• Product Code: DZE
• UDI-Device Identifier: 00844868013303
• UDI-Public: (01)00844868013303(17)230724(10)2018070999
• 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): 06/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2023
• Device Model Number: OSS585
• Device Catalogue Number: OSS585
• Device Lot Number: 2018070999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female