MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA UNID; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	B33225512-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having posterior spinal fusion from t4 to the pelvis with s2ai screws using unid rods for alif l5-s1 (30 deg lordotic graft), spo l2-3.It was reported that the unid rod broke around l4-l5 region. due to broken rod there was loosening of the alif implant at l5-s1.The rod also lost some of its bend overtime and the patient had lost some correction.From patient's x-rays it can be observed that the rod has been replaced and the surgeon added an extra fixture to secure/ stabilize the patient.Revision surgery was successfully completed on (b)(6) 2021 without any complications.Both rods were broken between l5 and s1 and they were completely explanted and replaced with new ones.There were no patient symptoms reported.There were no further complications reported regarding the event.

• Brand Name: UNID
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12932122
• Report Number: 1000432246-2021-00015
• Device Sequence Number: 11979377
• Product Code: MNI
• UDI-Device Identifier: 03613720268635
• UDI-Public: 03613720268635
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

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: Health Professional
• Device Model Number: B33225512-02
• Device Catalogue Number: B33225512-02
• Device Lot Number: UNKNOWN
• 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: 11/15/2021
• Initial Report FDA Received Date: 12/06/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male