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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC DEFIANCE FP PLUS; JOINT, KNEE, EXTERNAL BRACE

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DJO, LLC DEFIANCE FP PLUS; JOINT, KNEE, EXTERNAL BRACE Back to Search Results
Model Number CONV DEFIANCE FP PL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Damage to Ligament(s) (1952)
Event Date 08/28/2018
Event Type  Injury  
Event Description
It was reported that, after receiving clearance from his doctor and while playing in his first soccer game after 11 months of rehab, the patient collided with another player and re-tore his anterior cruciate ligament (acl).
 
Manufacturer Narrative
The brace was returned to the manufacturer for evaluation.Brace is in good condition and functional.The brace is built within specifications.No issues were found.
 
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Brand Name
DEFIANCE FP PLUS
Type of Device
JOINT, KNEE, EXTERNAL BRACE
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081 9663
MDR Report Key8277879
MDR Text Key134099972
Report Number3012446970-2019-00003
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 user facility
Type of Report Initial,Followup
Report Date 01/25/2019
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 PL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2019
Initial Date Manufacturer Received 01/11/2019
Initial Date FDA Received01/25/2019
Supplement Dates Manufacturer Received01/11/2019
Supplement Dates FDA Received01/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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