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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC DONJOY DEFIANCE FP PLUS; JOINT, KNEE, EXTERNAL BRACE
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DJO, LLC DONJOY DEFIANCE FP PLUS; JOINT, KNEE, EXTERNAL BRACE Back to Search Results
Model Number CONV DEFIANCE FP PLUS HINGES
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 07/15/2019
Event Type  Injury  
Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
 
Event Description
It was reported that while "playing basketball, [patient] was wearing the brace.He was playing on defense doing a side shuffle and felt a pop followed by terrible pain." no further information is currently available.
 
Manufacturer Narrative
H3, h6: one conv defiance fp (serial number: (b)(6) was returned for evaluation.The brace is in good condition and functional.Per the condition, functionality, and manufacturing form; the brace is built within specifications.No issues were found.
 
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Brand Name
DONJOY DEFIANCE FP PLUS
Type of Device
JOINT, KNEE, EXTERNAL BRACE
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081 9663
MDR Report Key9163363
MDR Text Key161922162
Report Number3012446970-2019-00038
Device Sequence Number1
Product Code ITQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCONV DEFIANCE FP PLUS HINGES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Initial Date Manufacturer Received 09/10/2019
Initial Date FDA Received10/07/2019
Supplement Dates Manufacturer Received09/10/2019
Supplement Dates FDA Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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