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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC DONJOY COOK, X-ACT ROM, POST-OP

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DJO, LLC DONJOY COOK, X-ACT ROM, POST-OP Back to Search Results
Model Number 11-2151-9
Device Problems Unintended Collision (1429); Mechanics Altered (2984)
Patient Problems Failure of Implant (1924); Limited Mobility Of The Implanted Joint (2671)
Event Date 12/28/2014
Event Type  Injury  
Event Description

Complaint received from clinician that alleges "patient hit her braces together resulting in the locked hinges unlocking and the patient buckled to the ground". "office visit notes" were received from clinician and/or patient. Patient unable to do straight leg raise that she was previously capable of doing, suspicion of partial reinjury to lateral aspect fo right quadriceps tendon. Device not returned to manufacturer for evaluation.

 
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Brand NameDONJOY
Type of DeviceCOOK, X-ACT ROM, POST-OP
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081
Manufacturer (Section G)
DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
carretera libre tijuana tecate
20230 submetropoli el florido
tijuana b.c. 2224 4
MX 22244
Manufacturer Contact
1430 decision street
vista, CA 92081
7607271280
MDR Report Key4454265
MDR Text Key5424953
Report Number9616086-2015-00003
Device Sequence Number1
Product Code IQI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/23/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number11-2151-9
Device Catalogue Number11-2151-9
Was Device Available For Evaluation? No
Date Manufacturer Received01/06/2015
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 Unkown

Patient TREATMENT DATA
Date Received: 01/26/2015 Patient Sequence Number: 1
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