inforMED
InjuryILZ

ANDREWS

Received Jul 23, 2001 · Event occurred Jun 2, 2001

Report 343698 · MDR key 343698

Device

Generic name

Prone Positioning Pillow

Model number

5819

Catalog number

NA

Lot number

NA

Product problems

  • Design/structure problem

Patient

59 YR

  • Blurred Vision
  • Disability

Narrative

Description of Event or Problem

LUMBAR LAMINECTOMY AND FUSION AT THE LEVEL OF L3, L4, L5 WITH NEUROLYSIS OF THE L3, L4, L5 ROUTES BILATERALLY. INTERTRANSVERSE FUSION AT L3-L4, L4-L5 USING LOCAL BONE GRAFT AND BONE MATRIX PASTE, AS WELL AS A POSTERIOR LUMBAR INTERBODY FUSION AT L3-L4, L4-L5 BILATERALLY USING SYNTHES ALLOGRAFT BONE PLUGS AND PEDICULAR SCREWS AND ROD FIXATION AT THE LEVEL OF L3, L4 AND L5 BILATERALLY WITH AN INTERCONNECTING TRANSVERSE BAR. PROCEDURE STARTED AT 0725 AND ENDED AT 1509. POSTOPERATIVELY, THE PT COMPLAINS OF BLURRED VISION IN THE LEFT EYE. OVER THE NEXT SEVERAL DAYS, THE VISION IMPROVES BUT A DEFICIT REMAINS. THE PHYSICIAN DISCUSSES THE CONDITION WITH THE PT AND TELLS PT THAT IT WILL PROBABLY IMPROVE AND RETURN TO NORMAL; TIME IS NECESSARY TO LET IT RECOVER. POSTOPERATIVE VISITS RESULT IN A DETERMINATION THAT VISUAL DEFICITS IN THE LEFT EYE ARE PERMANENT. THE PT'S EYESIGHT WAS LOST MOST LIKELY AS A RESULT OF CENTRAL RETINAL ARTERY OCCLUSION. ANALYSIS PERFORMED. TESTS PERFORMED: THE ANDREW TABLE SST-3000 WAS SET UP. THE INDIVIDUALS INVOLVED IN THE CASE REVIEWED THE SET UP AND DESCRIBED THE STEPS TAKEN TO POSITION THE PERSON ON THE TABLE. THE STEPS AND POSITIONING WERE OBSERVED AND THE HEADREST PILLOW WAS EXAMINED AND UTILIZED BY VARIOUS PERSONS IN THE ROOM. ALSO REVIEWED ARTICLES THAT DESCRIBED PTS UNDERGOING A SIMILAR SURGERY AND ENDING UP WITH A SIMILAR DEMISE. RESULTS OF THE TESTS: 1. PRESSURE SEEMS TO BE THE CAUSATIVE FACTOR. 2. THERE APPEAR TO BE AT LEAST THREE DESIGN FLAWS CONTRIBUTING TO OR PROMOTING PRESSURE. THE FIRST IS THE DESIGN OF THE FACIAL CUT OUT. BECAUSE IT DIRECTS THE ET TUBE TO THE SIDE OF THE FACE, THE HEAD IS FORCED TO LAY SLIGHTLY TO THE RIGHT, THEREBY PLACING MORE FORCE ON THE LEFT SIDE OF THE HEAD. IF A CUT OUT FOR THE ET TUBE WAS ON THE BOTTOM, IT WOULD FACILITATE MAINTAINING A CENTRAL HEAD POSITION. THE SECOND IS THE PROXIMITY OF THE BORDER OF THE CUT OUT OF THE EYES, NOSE AND MOUTH. SLIGHT CHANGES IN POSITIONING ALMOST GUARANTEE UNDUE PRESSURE ON PLACES THE CUT OUT IS DESIGNED TO ELIMINATE. THE THIRD IS THE STRUCTURE ITSELF. IT IS COMPOSED OF TWO MATERIALS OF FOAM. ONE IS SOFTER THAN THE OTHER. THEY ARE ATTACHED BY A LAYER OF ADHESIVE MATERIAL THAT PREDISPOSES THAT AREA TO A GREATER DEGREE OF HARDNESS THAN OTHER AREA ON THE HEADREST. AGAIN, A SLIGHT CHANGE IN HEAD POSITION MIGHT FORCE THE EYE OVER THIS AREA AND RESULT IN A GREATER DEGREE OF PRESSURE ON THE EYE.