MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® IMPLANT 3.25 X 13MM; DENTAL IMPLANT

Model Number	OSM313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
The doctor reports that two (2) implants were fractured two (2) and a half years after their placement in dental positions #12 and #22 respectively.The doctor informs that the patient did not suffer any impact on his health and that the patient must return 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 cmp-(b)(4).Product not returned.
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) the following fields 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 h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative two osseotite® implant 3.25 x 13mm (osm313) implants were not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use and risk files to address reported event.Dhr review was completed for the subject lot number (2016020965).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, 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 (2016020965) for similar event using keywords fracture implant and no other complaints were identified.Therefore, based on the available information, device malfunction and the reported events could not be verified as the exact details of event were non-verifiable and the products were not returned.

• Brand Name: OSSEOTITE® IMPLANT 3.25 X 13MM
• 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: 12287681
• Report Number: 0001038806-2021-01459
• Device Sequence Number: 17095474
• Product Code: DZE
• UDI-Device Identifier: 00844868012962
• UDI-Public: (01)00844868012962(17)210301(10)2016020965
• 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: 2019
• 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,Followup
• Report Date (Section B): 12/13/2021

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: Lay User/Patient
• Device Expiration Date: 03/01/2021
• Device Model Number: OSM313
• Device Catalogue Number: OSM313
• Device Lot Number: 2016020965
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/15/2021
• 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: 07/15/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 12/10/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/21/2021; 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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 Age: 76 YR
• Patient Sex: Male