MAUDE Adverse Event Report: BIOMET 3I BELLATEK¿ HYBRID BAR 5 IMPLANTS; DENTAL BAR

Model Number	CSHY05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bar is broken at implant number 5.The cylinder is almost bisected with the distal extension attached.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Additional Manufacturer Narrative
One bellatek hybrid bar 5 implants (cshy05) was reported but not returned for investigation.Therefore, visual/physical evaluation could not be performed.The investigation was completed using only the available information.Functional testing could not be performed due to the nature of the device and event.No pre-existing conditions were noted.Images of scan were provided.The reported event could not be verified.Appropriate documents were reviewed.Dhr review was completed for the subject lot number (8624176-1).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.A lot specific complaint history review is not conducted for psp complaints.Patient specific products have a unique one time use lot number.Therefore, a lot specific history search for this complaint is not performed.March post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Based on the available information, device malfunction and the reported event could not be verified.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BELLATEK¿ HYBRID BAR 5 IMPLANTS
• Common Device Name: DENTAL BAR
• 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: 16241094
• Report Number: 0001038806-2023-00138
• Device Sequence Number: 6523214
• Product Code: NHA
• UDI-Device Identifier: 00844868001683
• UDI-Public: (01)00844868001683(10)8624176-1
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K080864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: Lay User/Patient
• Device Model Number: CSHY05
• Device Catalogue Number: CSHY05
• Device Lot Number: 8624176-1
• Was Device Available for Evaluation?: No
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2021
• 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
• Patient Sex: Unknown