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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL (DEPUY SPINE, INC.) EXPEDIUM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

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MEDOS INTERNATIONAL SARL (DEPUY SPINE, INC.) EXPEDIUM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS Back to Search Results
Model Number 179702535
Device Problem Insufficient Information (3190)
Patient Problem Paraplegia (2448)
Event Date 06/06/2017
Event Type  Injury  
Event Description

A young girl with severe adolescent idiopathic scoliosis presented for elective posterior spinal fusion and bone grafting of t4-l4 vertebrae, as well as epidural catheter placement at t6 and t12. The patient was transported to the or at 0739. Motor potentials were unable to be obtained from the start of the surgery. Two dimensional c-arm x-rays were completed intra-op. No concerns were noted. The surgery was completed at 1457 without any challenges. A "wake up" test was performed per recommended guidelines to assess sensorimotor functioning in the absence of intra-op monitoring. Upon awaking, the patient was unable to move her feet. She was extubated and brought to the post anesthesia unit for full wake-up. She had sensation of her legs but was unable to move them. She had an emergent ct scan that showed 3 pedicle screws in the spinal canal. She was brought back to the or to have the screws removed. She continued to have incomplete paraplegia after surgery, including a loss of bowel and bladder control. She was treated with decadron and ketorolac. She regained some movement in her left lower extremity and was reporting bladder fullness and the sensation to void. Last report is that the patient is at home walking with crutches, using a wheelchair when fatigued. Range of motion on her right lower extremity is nearly normal but still lacks strength. Her bladder control is improving, with less retention when voiding, but straight catheterizations are still required.

 
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Brand NameEXPEDIUM
Type of DevicePEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL (DEPUY SPINE, INC.)
karen mahoney
325 paramount dr
raynham MA 02767
MDR Report Key7103784
MDR Text Key94394160
Report Number7103784
Device Sequence Number0
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2017
Is This An Adverse Event Report? Yes
Device Operator
Device MODEL Number179702535
Device Catalogue Number179702535
OTHER Device ID NumberMONOAXIAL SCREW
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/08/2017
Device Age1 dy
Event Location Hospital
Date Report TO Manufacturer12/08/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/11/2017 Patient Sequence Number: 1
Treatment
LIFENET HEALTH. ID: (B)(6) CODE: CC1/4 EX
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