FDA Adverse Event Injury Summary report: N

BLEDSOE EXTENDER PLUS KNEE BRACE

MDR report key: 1700437 · Received May 23, 2010

Report

Report Number
MW5016083
Event Type
Injury
Date Received
May 23, 2010
Date of Event
May 1, 2010
Report Date
May 23, 2010
Manufacturer
BLEDSOE BRACE SYSTEMS
Product Code
ITQ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B) (6) 2010, MY (B) (6) OLD SON UNDERWENT ACL RECONSTRUCTION OF HIS LEFT KNEE. HIS SURGERY WAS PERFORMED BY DR (B) (6) OF (B) (6). POST-OP, ON (B) (6) HE WAS FITTED WITH A BLEDSOE EXTENDER PLUS KNEE BRACE BY (B) (6) FROM (B) (6). THE BRACE WAS SET AT 40 DEGREES AND LOCKED INTO POSITION WITH PLASTIC SAFETY TIES. ON (B) (6) 2010, AS HE WAS GOING DOWN 3 STAIRS, THE BRACE HINGE FAILED AND THE SETTINGS ON THE BRACE SHIFTED FROM 40 DEGREES TO 60 DEGREES ON ONE SIDE AND 70 DEGREES ON THE OTHER CAUSING MY SON'S PATELLA TO FRACTURE - THE FRACTURE WAS DIAGNOSED BY DR (B) (6) ON (B) (6) 2010. ON (B) (6) 2010, DUE TO THE BRACE FAILURE, MY SON UNDERWENT ANOTHER SURGERY AND HAD THREE SCREWS INSERTED INTO HIS PATELLA TO REPAIR THE FRACTURE. SINCE THE INITIAL BRACE HINGE FAILURE, HE HAS BEEN FITTED WITH TWO NEW BLEDSOE EXTENDER PLUS KNEE BRACES AND HAS EXPERIENCED THE SAME UNEXPLAINED HINGE MOVEMENT, EVEN THOUGH THE HINGES WERE SET AND LOCKED WITH SAFETY TIES, AS ON THE FIRST BRACE. THE ONLY DIFFERENCE BEING THAT THE HINGE MOVEMENT ON THE TWO REPLACEMENT BRACES OCCURRED AS HE WAS PREPARING TO SIT -SO THERE WAS NO WEIGHT ON THE BRACE AT ALL- WHICH NECESSITATED UNLOCKING THE BRACE FROM A STRAIGHTENED POSITION SO THAT HIS LEG WOULD HAVE A SLIGHT BEND AT 30 DEGREES. PRIOR TO THE EVENT, HE WAS PRESCRIBED PT 3X PER WEEK. DUE TO NEW INJURY, PT HAS BEEN SUSPENDED UNTIL AT LEAST (B) (6) TO GIVE PATELLA TIME TO HEAL. REHAB FOR AN ACL RECONSTRUCTION INCLUDES MOVING THE AFFECTED KNEE AS MUCH AS POSSIBLE. REHAB FOR A PATELLAR FRACTURE INVOLVES IMMOBILIZING THE JOINT. DATES OF USE: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: ACL RECONSTRUCTION OF THE LEFT KNEE USING THE PATELLAR TENDON.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BLEDSOE EXTENDER PLUS KNEE BRACE POST-OP KNEE BRACE ITQ BLEDSOE BRACE SYSTEMS HCFA CODE: L1832

Patients

Seq Age Sex Outcome Treatment
1 17 YR Other