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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
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 patient underwent an indirect decompression spacer implant procedure at the l4-l5 vertebrae.Upon final placement of the spacer in the patient, the physician suspected the lamina had fractured.The physician then removed the spacer from the patient, obtained homeostasis, and closed the incision.Due to the suspected 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 location of device is unknown.
 
Event Description
It was reported that the patient underwent an indirect decompression spacer implant procedure at the l4-l5 vertebrae.Upon final placement of the spacer in the patient, the physician suspected the lamina had fractured.The physician then removed the spacer from the patient, obtained homeostasis, and closed the incision.Due to the suspected 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 location of device is unknown.Additional information was received that the spacer was discarded by the medical facility the lot number for this device is unknown.
 
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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 Key15534039
MDR Text Key301085780
Report Number3006630150-2022-05235
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000536
UDI-Public00884662000536
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
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 Number101-9810
Device Catalogue Number101-9810
Device Lot Number800318
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/07/2022
Initial Date FDA Received10/03/2022
Supplement Dates Manufacturer Received10/17/2022
Supplement Dates FDA Received10/31/2022
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 Number1
Patient Outcome(s) Other; Hospitalization; Required Intervention;
Patient Age80 YR
Patient SexFemale
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