inforMED
InjuryMBP

GRAFTON PLUS DBM 10 ML

Received Aug 1, 2022 · Event occurred Jul 30, 2022

Report MW5111225 · MDR key 15147850

Device

Generic name

Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

Model number

T45010

Product problems

  • Patient-Device Incompatibility

Patient

67 YR · Female

  • Hypersensitivity/Allergic reaction
  • Muscle Weakness/Atrophy
  • Nervous System Injury
  • Hypersensitivity/Allergic reaction
  • Muscle Weakness/Atrophy
  • Nervous System Injury

Narrative

Description of Event or Problem

THE PATIENT UNDERWENT POSTERIOR CERVICAL DECOMPRESSION AND FUSION FOR RESECTION OF A TUMOR. MEDTRONIC GRAFTON PLUS DBM (A STANDARD BONE GRAFT USED IN SPINE SURGERY) WAS USED AS ALLOGRAFT TO SUPPLEMENT THE LOCAL AUTOGRAFT. IT WAS APPLIED TO THE FACET JOINTS IN STANDARD FASHION. THE SPINAL CORD WAS COMPLETELY FREE OF COMPRESSION AT WOUND CLOSURE. A SURGICAL DRAIN WAS PLACED AND REMOVED POSTOP DAY 2 AFTER OUTPUT WAS SATISFACTORILY LOW. THE PATIENT WAS NEUROLOGICALLY STABLE UNTIL POSTOP DAY 5, WHEN SHE WHEN ACUTELY DECOMPENSATED FROM FULL 5/5 STRENGTH IN ALL EXTREMITIES TO 0/5 STRENGTH IN THE DISTAL UPPER EXTREMITIES AND ENTIRE LOWER EXTREMITIES. MRI DEMONSTRATED A LARGE FLUID COLLECTION IN THE SURGICAL BED CAUSING CORD COMPRESSION, AND THE PATIENT WAS EMERGENTLY RETURNED TO THE OPERATING ROOM. THE FLUID COLLECTION HAD A THIN, OFF-WHITE APPEARANCE WITH PIECES OF THE MEDTRONIC GRAFTON PLUS DBM MIXED IN WITH IT. THERE WAS NO HEMATOMA, PUS, OR CSF (MORE TYPICAL CAUSES OF POSTOPERATIVE COLLECTIONS). WE SUSPECT THAT THE PATIENT HAD AN ALLERGIC REACTION TO ONE OF THE PROCESSING AGENTS IN BONE GRAFT (E.G. SURFACTANT OR ANTIBIOTICS), A FLUID COLLECTION RESULTED FROM THE INFLAMMATORY RESPONSE. DIAGNOSIS FOR USE: BONE GRAFT FOR SPINE SURGERY.