inforMED
InjuryITQ

CORETECH ROM KNEE IMOBILIZER

Received Nov 14, 2025 · Event occurred Oct 6, 2025

Report 23553689 · MDR key 23553689

Device

Generic name

Joint, Knee, External Brace

Manufacturer

Vive Health Llc

Model number

SUP2071BLK

Product problems

  • Material Twisted/Bent

Patient

69 YR · Male

  • Pain
  • Pain

Narrative

Description of Event or Problem

PATIENT STANDING IN PARALLEL BARS IN R [RIGHT] HINGED KNEE IMMOBILIZER (WBAT) AND NWB [NON WEIGHT BEARING] ON L LE [LEFT LOWER EXTREMITY] IN IMMOBILIZER (NON-HINGED), PERFORMING 3RD REP OF L HIP FLEXION WITH WHEELCHAIR BEHIND PATIENT, WHILE STANDING ON R LE [RIGHT LOWER EXTREMITY] AND R KNEE BUCKLED WHILE BRACE WAS STILL LOCKED IN EXTENSION. PATIENT SUPPORTED SELF ON PARALLEL BARS AND THERAPIST ASSISTED TO PREVENT FALL WHILE 2ND THERAPIST ASSISTED IN MOVING WHEELCHAIR UNDER PATIENT'S BUTTOCKS. UPON INSPECTION OF THE BRACE, BRACE STILL LOCKED IN EXTENSION, BUT SUPPORT BARS WERE TWISTED. ALERTED MD AND RN. RN PRESENT TO ASSESS PATIENT. PAIN REPORTS AT R KNEE OF 2/10. STAT IMAGING ORDERED BY MD.