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

Model Number	B33126012-02
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having t4 - l1 pediatric orthopedic surgery for an indication of adolescent idiopathic scoliosis (ais).It was reported that the rod has fractured and currently remains in the patient. the initial surgery was performed on (b)(6) 2017 and the additional surgery was performed on (b)(6) 2021. an additional satellite rod was connected via dominos to the fractured rod.No need for any removal per surgeon.There were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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.
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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 t4 - l1 pediatric orthopedic surgery for an indication of adolescent idiopathic scoliosis (ais).It was reported that the rod has fractured and currently remains in the patient. the initial surgery was performed on (b)(6) 2017 and the additional surgery was performed on (b)(6) 2021. an additional satellite rod was connected via dominos to the fractured rod.No need for any removal per surgeon.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: 13164450
• Report Number: 1000432246-2022-00002
• Device Sequence Number: 5335514
• Product Code: MNI
• UDI-Device Identifier: 03613720268970
• UDI-Public: 03613720268970
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 01/05/2022

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: B33126012-02
• Device Catalogue Number: B33126012-02
• 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: 12/09/2021
• Initial Report FDA Received Date: 01/05/2022
• 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: Female