MAUDE Adverse Event Report: OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) NOT REPORTED

Model Number NOT REPORTED

Device Problem Insufficient Information (3190)

Patient Problems Neuropathy (1983); Pain (1994); Post Operative Wound Infection (2446)

Event Date 05/18/2013

Event Type  Injury  

Event Description

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.¿.

Manufacturer Narrative

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.

• Brand Name: NOT REPORTED
• Manufacturer (Section D): OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC); 201 industrial way west; eatontown NJ 07724
• Manufacturer (Section G): OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC); 201 industrial way west; eatontown NJ 07724
• Manufacturer Contact: edward wheeler ; 201 industrial way west; eatontown, NJ 07724 ; 7325422800
• MDR Report Key: 3866286
• MDR Text Key: 4510203
• Report Number: 2246640-2014-00007
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT REPORTED
• Device Catalogue Number: NOT REPORTED
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 06/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability