MAUDE Adverse Event Report: BIOMET 3I 3I T3® PARALLEL WALLED IMPLANT 4/3 X 13MM; DENTAL IMPLANT

Model Number	BOPS4313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported fracture of abutment screw at tooth site 25.Unable to removed screw, implant was also removed.Doctor's assistant confirmed by phone that implant fractured when removing the screw.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional device information unknown / not provided.Email address unknown / not provided.Device manufacturer date unknown / not provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One certain® low profile one-piece abutment 3.4mm(d) x 2mm(h), ilpc342u & one 3i t3® parallel walled implant 4/3 x 13mm, bops4313 was returned for investigation.Visual inspection via naked eye and camera magnification was completed.The abutment was fractured at the screw threads.Damage observed on the returned implant due to removal is not considered a malfunction or failure of the device.Zimvie 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 (2016100964).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 (2012030146) for similar event (complaint category keywords: fracture screw) and revealed no existing non-conformances/capa/hhe/d/ie/product holds for the reported product.Based on the available information, device malfunction did occur and the reported event was confirmed following inspection and evaluation.
Event or Problem Description
No further event information is available at the time of the report.

• Brand Name: 3I T3® PARALLEL WALLED IMPLANT 4/3 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: 13584454
• Report Number: 0001038806-2022-00254
• Device Sequence Number: 4410437
• Product Code: DZE
• UDI-Device Identifier: 00844868028413
• UDI-Public: (01)00844868028413(17)211026(10)2016100964
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/03/2022

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: Lay User/Patient
• Device Expiration Date: 10/26/2021
• Device Model Number: BOPS4313
• Device Catalogue Number: BOPS4313
• Device Lot Number: 2016100964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• 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: 02/03/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2016
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 90 KG