MAUDE Adverse Event Report: SEASPINE, INC. MALIBU POLYAXIAL SCREW 7.5 X 45 MM

Catalog Number 12-7545

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cerebrospinal Fluid Leakage (1772); Purulent Discharge (1812); Pain (1994); Swelling (2091); Post Operative Wound Infection (2446); Test Result (2695)

Event Date 07/17/2014

Event Type  Other  

Event Description

This is the fourth report of six concerning the same pt.This report concerns 12-7545 malibu polyaxial screw 7.5x45mm.It was reported the pt was first operating on (b)(6) 2014 where she underwent a lumbar fusion procedure using 11 malibu screws, 2 rods, and 2 cross bars, 10 x 10cc of eliz and 10x 5cc osiq bone graft.The pt later presented as an in pt at st (b)(6) hosp in (b)(6) with wound infection, a dural leak and severe pain.Scans showed some misplaced screws.The surgeon felt this accounted for the pain and the dural leak.The scans also showed a large volume of fluid with the graft migrated out to the margins of the fluid sack.The surgeon performed a revision surgery on (b)(6) 2014 removing all graft and hardware and cleaning out the wound.Three hundred (300ml) of pus was collected from a superficial swelling.The graft migrated from the spine to the soft tissues with the flow of the fluid through a fascial hole.The infection was confirmed as enterococcus faecalis.Because of the infection, the surgeon decided it was inadvisable to replace the hardware and as the spine appeared to remain stable he said this should not cause a problem.The source of the infection could not be confirmed.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported info.

• Brand Name: MALIBU POLYAXIAL SCREW 7.5 X 45 MM
• Type of Device: MALIBU
• Manufacturer (Section D): SEASPINE, INC.; vista CA 92081
• Manufacturer Contact: caren finkelstein ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4115186
• MDR Text Key: 4836630
• Report Number: 2032593-2014-00043
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12-7545
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 10 X 10CC OF ELIZ; 10X 5CC OSIQ BONE GRAFT
• Patient Outcome(s): Hospitalization; Required Intervention