PMT
Received Jan 23, 1997
Report 2182979-1996-00038 · MDR key 65285
Device
Product problems
- Failure To Adhere Or Bond
- Inadequacy of Device Shape and/or Size
- Fitting Problem
Patient
14 YR
- No Consequences Or Impact To Patient
- Nonspecific
Narrative
Description of Event or Problem
ANTERIOR HALO VEST "POPPED OFF" (AT CHEST BLOCK SITE) FROM 14 Y/O, OBESE, MALE PT. ORIGINAL DIAGNOSIS/REASON FOR HALO APPLICATION IS UNKNOWN. ORTHOPEDIC NURSE REPORTED PT WAS HARD TO FIT DUE TO HIS WEIGHT AND PROTUBERANT ABDOMEN. A SIZE LARGE VEST WAS CLAIMED TO HAVE BEEN APPLIED ORIGINALLY. BUT THE PHYSICIAN DID NOT LIKE THE FIT, FEELING IT WAS TOO BIG IN THE SHOULDERS. A SIZE MEDIUM VEST WAS THEN USED. THE INCIDENT OCCURRED SIX WEEKS AFTER APPLICATION. NO INJURY OR TRAUMA TO THE PT WAS REPORTED AND HE REMAINED STABLE. THE ANTERIOR VEST WAS REPLACED IMMEDIATELY FROM THE SALES REP'S STOCK. LOT NUMBER IS UNKNOWN. CHEST BLOCKS ARE COMPOSED OF TWO PARTS, A BASE WITH PROTRUDING SCREWS AND A TOP PIECE WITH HOLES FOR ROD INSERTION. ALLEGED INCIDENT OCCURRED WHEN TOP PIECE CAME OFF BASE. CUSTOM VEST COULD HAVE PROVIDED A BETTER FIT.
Remedial action
- Replace