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

Model Number 101-9814

Device Problem Migration (4003)

Patient Problems Fall (1848); Hemorrhage/Bleeding (1888); Pain (1994); Paralysis (1997); Numbness (2415); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/11/2021

Event Type  Injury  

Event Description

It was reported by the patient's daughter that immediately following a superion indirect decompression spacer implant procedure, the patient was in pain and had a charlie horse in her right leg.The patient was administered norco.The patient could not move her right leg, which made it difficult to walk.Later that night, the patient was not able to urinate.The daughter noticed that the incision was bleeding and called 911.When the patient leaned forward so that the daughter could examine the incision, the patient fell out of the chair and onto her face.The patient was taken to the hospital where an x-ray was taken which showed that the spacer had migrated into the spinal canal.The patient was diagnosed with cauda equina.The following day, the patient was transferred to another hospital where the physician performed a spacer explant procedure roughly thirty eight hours after the implant procedure.The patient is now in a rehabilitation center where she is undergoing physical therapy to regain strength.The patient is now able to walk, however, her feet are numb.

• 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; 2714 loker ave. west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12425874
• MDR Text Key: 270306979
• Report Number: 3006630150-2021-04954
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• UDI-Public: 00884662000550
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 800217
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• 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