MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 101-9810

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Spinal Cord Injury (2432); Vertebral Fracture (4520)

Event Date 09/18/2021

Event Type  Injury  

Event Description

It was reported that the clinical study patient underwent an indirect decompression spacer implant procedure at the l3-l4 vertebrae.The physician suspected the lamina had fractured and removed this spacer from the patient.Homeostasis was obtained and the incision was closed.Due to the fracture, the patient was hospitalized for observation.Two days later the patient underwent an l5 bilateral laminectomy and decompression of the neural arthrodesis of l5 vertebra and s1.It was noted that the patient had a fractured lamina and compression of the neural tube with fragments of bone and redundant yellow ligament.The patient was in stable condition postoperatively and discharged several days following the procedure.There were no neurological complications due to the event.The event was assessed as not related to the device; however, it was assessed as having a causal relationship to the procedure.The device will not be returned as it was discarded by the medical facility.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): VERTIFLEX INC; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15705363
• MDR Text Key: 302763987
• Report Number: 3006630150-2022-05875
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000536
• UDI-Public: 00884662000536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140004
• 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: 10/31/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization; Other
• Patient Age: 80 YR
• Patient Sex: Female