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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC COOL, X-ACT ROM LITE, POST OP; JOINT, KNEE, EXTERNAL BRACE
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DJO, LLC COOL, X-ACT ROM LITE, POST OP; JOINT, KNEE, EXTERNAL BRACE Back to Search Results
Model Number 11-2161-9
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2018
Event Type  malfunction  
Manufacturer Narrative
The device is not available for evaluation.If it becomes available, a follow-up report will be submitted upon completion of the evaluation.
 
Event Description
It was reported that the patient informed physiotherapy staff that the xact rom knee brace had broken; the metal had snapped when the brace was locked at 90 degrees.No further information has been provided.
 
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Brand Name
COOL, X-ACT ROM LITE, POST OP
Type of Device
JOINT, KNEE, EXTERNAL BRACE
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081 9663
Manufacturer (Section G)
DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
carretera libre tijuana tecate
20230 submetropoli el florido
tijuana, b.c. 22244,
MX  
Manufacturer Contact
brian becker
2900 lake vista drive
lewisville, TX 75067
MDR Report Key8491129
MDR Text Key141184471
Report Number9616086-2019-00017
Device Sequence Number1
Product Code ITQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number11-2161-9
Was Device Available for Evaluation? No
Date Manufacturer Received03/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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