MAUDE Adverse Event Report: ORTHOFIX CETRA; CETRA 3 LEVEL PLATE ASSEMBLY, 58MM

Model Number	19-0358
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was stated that in two separate events the cetra 3 level plates had the locking mechanism pop off and therefore the screw backed out.In both situations it was a three level plate with the broken locking mechanism and screw back out on the bottom of the construct.
Additional Manufacturer Narrative
Pending additional information.
Additional Manufacturer Narrative
Pending additional information.
Event or Problem Description
It was stated that the cetra 3 level plate had the locking mechanism pop off and therefore the screw backed out.The broken locking mechanism and screw back out was on the bottom of the construct.Device was not explanted so was not returned for investigation.Doctor is monitoring patient.Patient is doing well at this time.Rev.1 note: refer to report # 2183449-2024-00018.On initial report information was duplicated and/or flipped between the two reports.Revision 1 adds additional information obtained and clears up any duplication of information between the reports.

• Brand Name: CETRA
• Common Device Name: CETRA 3 LEVEL PLATE ASSEMBLY, 58MM
• Manufacturer (Section D): ORTHOFIX; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: james stephens ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 20273791
• Report Number: 2183449-2024-00017
• Device Sequence Number: 7315498
• Product Code: KWQ
• UDI-Device Identifier: 18257200120550
• UDI-Public: 18257200120550
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K162638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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?: No
• Device Model Number: 19-0358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female