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

Model Number B33225512-02

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 286920709
• Report Number: 1000432246-2021-00015
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 03613720268635
• UDI-Public: 03613720268635
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male