MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-06-11 for NOT REPORTED manufactured by Osteotech, Inc (subsidiary Of Medtronic).
[4510203]
It was reported that a patient underwent a cervical decompression, fusion and instrumentation "with implantation of an allograft. " in the several days following surgery, the patient reportedly "began developing clinical signs and symptoms of infection. " two days post-op, the patient reportedly began to develop bilateral arm pain, which progressively worsened. The operating surgeon reportedly noted that the patient was weak in his shoulders and deltoids, and had significant pain radiating from his neck into his arms and forearms. The surgeon reportedly also noted wound drainage, and that "the dressing has not been taken down over the weekend and (the patient) definitely had some wound drainage. " four days post-op, the patient was taken back to surgery for an emergency irrigation and debridement, at which time the wound was cultured. The wound cultures were positive for serratia marcescens. Two days later, the patient was again taken to the operating room for irrigation and debridement. Three days later, the patient returned to the operating room again for irrigation and debridement with removal of the bone graft. Two days later additional irrigation and debridement was performed, and two days later irrigation and debridement with wound closure. The patient was discharged from the hospital approximately 18 days after his initial surgery. In his discharge summary, the surgeon reportedly noted that the patient "did acquire a nosocomial posterior wound infection, which led to the subsequent wash out. " subsequent to his discharge, the patient reportedly developed a severe right upper trunk brachial plexopathy with evidence of axon loss. It was reported that the patient? Continues to require medical care and treatment.?
Patient Sequence No: 1, Text Type: D, B5
[12088002]
This medwatch report was completed using the information provided by the initial reporter. Any missing or incomplete information is the result of the information not having been reported by the initial reporter. (b)(6). No part number or lot/serial number was reported; therefore, no additional review of the reported event, or of any device history record, is possible without additional device information. A definitive cause for this reported event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246640-2014-00007 |
| MDR Report Key | 3866286 |
| Report Source | 00 |
| Date Received | 2014-06-11 |
| Date of Report | 2014-05-13 |
| Date of Event | 2013-05-18 |
| Date Mfgr Received | 2014-05-13 |
| Date Added to Maude | 2014-06-12 |
| 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 | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EDWARD WHEELER |
| Manufacturer Street | 201 INDUSTRIAL WAY WEST |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal | 07724 |
| Manufacturer Phone | 7325422800 |
| Manufacturer G1 | OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) |
| Manufacturer Street | 201 INDUSTRIAL WAY WEST |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOT REPORTED |
| Product Code | MBP |
| Date Received | 2014-06-11 |
| Model Number | NOT REPORTED |
| Catalog Number | NOT REPORTED |
| Lot Number | NOT REPORTED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) |
| Manufacturer Address | 201 INDUSTRIAL WAY WEST EATONTOWN NJ 07724 US 07724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2014-06-11 |