MAUDE Adverse Event Report: BIOMET 3I BELLATEK¿ HYBRID BAR 4 IMPLANTS; DENTAL BAR

Model Number	CSHY04
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Patient age is not provided / unknown.Patient weight is not provided / unknown.Date of event is not provided / unknown.Initial reporter¿s title and last name are not provided / unknown.
Event or Problem Description
It was reported that the bar broke in patient's mouth and will need to be remade.The patient will still wear the bar until the new one is made.The fracture occurred around tooth #27 on the side of the last implant.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The date of event is known.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The product was not returned.The reported event could not be verified.Based on the evaluation, device malfunction could not be verified.There is no existing nonconformance / capa / hhe/d/ie/product holds against the reported device that could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.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.A definitive root cause could not be determined.No further investigation and no immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: BELLATEK¿ HYBRID BAR 4 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: 16287582
• Report Number: 0001038806-2023-00193
• Device Sequence Number: 4942724
• Product Code: NHA
• UDI-Device Identifier: 00844868001676
• UDI-Public: (01)00844868001676(17)300718(10)8571241-1
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 05/19/2023

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: CSHY04
• Device Catalogue Number: CSHY04
• Device Lot Number: 8571241-1
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 02/02/2023; 05/03/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/03/2023; 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female