MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,03,07 report with the FDA on 2012-11-14 for NUT manufactured by .
[3076954]
(b)(6) female experienced mva in 2004. The l5 fracture was treated with short segment posterior stabilization: l4-l5 in first stage followed by anterior l5 corpectomy, instrumentation and fusion. Anterior stabilization was done from l4-s1 with pedicle screw and rod, synthes universal spinal system. Anterior column reconstruction completed with harms mesh cage filled with bone graft. Patient had regular follow ups for 2 years. Radiographs showed signs of anterior fusion. After 5 years patient presented with complaints of occasional bleeding from rectum. Patient treated with medications. After 6 mo. Patient presented to er with complaints of heavy bleeding from the rectum. Colonoscopy showed distal end of anterior rod eroded the wall of the sigmoid colon. Ct scan showed erosion of left common iliac artery by the proximal end of the implant. Hardware was removed approximately 2009. Explorative laparatomy and adhesiolysis was performed and showed perforation of the rectosigmoid colon by the distal end of anterior rod and proximal screw head was found to be eroding the left common iliac artery. Arterial reconstruction performed, low anterior resection anastomosis of the rectum along with diversion loop ileostomy. Post op period was uneventful, after 1 week uretric stent was removed, and after 6 weeks colostomy closure completed. Regular follow ups were completed and patient recovered from chronic anemia. The reporting product development engineer noted: the uss system is indicated for anterolateral fixation from t8 to l5. The images within the article show anterior placement from the lumbar spine to the sacrum. The off-label use contributed to post op complications described in the article. This is 7 of 7 reports for this event.
Patient Sequence No: 1, Text Type: D, B5
[10301479]
Implant date approximately 2004. Explant date approximately 2009. (b)(6). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-03137 |
| MDR Report Key | 2830998 |
| Report Source | 00,03,07 |
| Date Received | 2012-11-14 |
| Date of Report | 2012-10-17 |
| Date Mfgr Received | 2012-10-17 |
| Date Added to Maude | 2012-11-14 |
| 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 | SHERRY LAING |
| 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 | NUT |
| Product Code | LYT |
| Date Received | 2012-11-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-11-14 |