MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-09-14 for CAP manufactured by Synthes (usa).
[2891020]
Pt suffering from back and right l5 dermatomal reference pain for 3 months before presenting to clinic october 2010. X-rays showed grade 1 spondylolsythesis. The mri report l5-s1 spondylolsythesis showed bilateral severe narrowing of the neural foramina with compression of the exiting l5 nerve roots, which appeared to be worse on the left side. Pt underwent a procedure for primary bilateral lumbar discectomy and posterior fusion, l5-s1 on (b)(6) 2011. During the procedure nerve roots were noted as swollen and a decision was made not to place plif cages. Upon the 1st post-operative review on (b)(6) 2011, pt complained of hypersensitivity and pain right l5 dermatome below the knee. Pt had begun physiotherapy. On (b)(6) 2011, the 2nd post-operative review noted pt as struggling with severe pain right l5 and s1 dermatomes. On (b)(6) 2012, pt was still complaining of pain and received an epidural injection to help relieve pain. On (b)(6) 2012, pt continued to complain of pain and an mri and ct was ordered. Ct showed loss of bone around the l5 screws, both through the pedicle and within the vertebral body, which is more marked on the left side. Hardware appeared to be satisfactory. This is the 7th of 10 reports submitted on this event.
Patient Sequence No: 1, Text Type: D, B5
[10184437]
Investigation is ongoing; no conclusion could be drawn as no device was returned or catalog number or lot number provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-01916 |
| MDR Report Key | 2750029 |
| Report Source | 01,07 |
| Date Received | 2012-09-14 |
| Date of Report | 2012-08-16 |
| Date of Event | 2012-08-03 |
| Date Mfgr Received | 2012-08-16 |
| Date Added to Maude | 2012-09-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARISSE BALL |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CAP |
| Product Code | LYT |
| Date Received | 2012-09-14 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | WEST CHESTER PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-14 |