MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-11 for EXPEDIUM 179702535 manufactured by Medos International Sarl (depuy Spine, Inc.).
[94394159]
Patient Sequence No: 1, Text Type: N, H10
[94394160]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7103784 |
| MDR Report Key | 7103784 |
| Date Received | 2017-12-11 |
| Date of Report | 2017-12-08 |
| Date of Event | 2017-06-06 |
| Report Date | 2017-12-08 |
| Date Reported to FDA | 2017-12-08 |
| Date Reported to Mfgr | 2017-12-08 |
| Date Added to Maude | 2017-12-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPEDIUM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS |
| Product Code | OSH |
| Date Received | 2017-12-11 |
| Model Number | 179702535 |
| Catalog Number | 179702535 |
| ID Number | MONOAXIAL SCREW |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SARL (DEPUY SPINE, INC.) |
| Manufacturer Address | KAREN MAHONEY 325 PARAMOUNT DR RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2017-12-11 |