MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-13 for PEDICLE SCREWS manufactured by .
[31581074]
On (b)(6) 2014, i had l2-s1 fused with two brackets and 10 screws. About a month ago, i bent over to adjust something and i felt extremely sharp pains in my back. Over the ensuing couple of weeks, my left leg went numb. After many x-rays and mris, my surgeon found that the top two screw fasteners had broken, thus allowing the l2-l3 disc to herniate. On (b)(6) 2015, i was operated on to remove the two offending screws and fasteners that broke, and replace them with two new screws and fasteners. Plus he cleaned out the heavily herniated disc and replaced it with a synthetic disc. I still have much back pain and my left leg is still partially numb. I cannot lift my left leg to climb stairs, and i need a cane to walk. L2-s1 back fusion. (b)(6); (b)(6) 2014 l2-l3 repair back fusion breaking by replacing 2 screws and two screw fasteners that had broken. (b)(6); (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057949 |
| MDR Report Key | 5235248 |
| Date Received | 2015-11-13 |
| Date of Report | 2015-11-13 |
| Date of Event | 2015-10-29 |
| Date Added to Maude | 2015-11-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | PEDICLE SCREWS |
| Generic Name | PEDICLE SCREWS |
| Product Code | NKB |
| Date Received | 2015-11-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Brand Name | PEDICLE SCREWS |
| Generic Name | PEDICLE SCREWS |
| Product Code | NKB |
| Date Received | 2015-11-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Brand Name | FASTENER |
| Generic Name | FASTENER |
| Product Code | MBJ |
| Date Received | 2015-11-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Brand Name | FASTENER |
| Generic Name | FASTENER |
| Product Code | MBJ |
| Date Received | 2015-11-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-11-13 |