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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL DYNAMICS RAY THREADED FUSION CARE DEVICE
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SURGICAL DYNAMICS RAY THREADED FUSION CARE DEVICE Back to Search Results
Model Number A02003530091
Device Problem Break (1069)
Patient Problems Pain (1994); Tingling (2171); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Disability (2371); Numbness (2415); Weight Changes (2607)
Event Date 03/17/1999
Event Type  Injury  
Event Description
Pt reported he had fusion cage device implanted on (b)(6) 1999 exactly a week after implantation he started experiencing chronic pain that radiates to the neck and lower back, stabbing and pinching sensation, tingling, depression, anxiety, weight loss, numbness and g.I issues.Pt reports this has caused him to be on disability.He has had five surgeries with no improvement to his symptoms.He saw his specialist on (b)(6) 2014 and was advised the device is broken as seen mri taken that day.Pain specialist administered pain injection to help alleviate the unbearable pain.He has an upcoming appointment on (b)(6) 2014.Pt is concerned the device is not only broken but expired as well.
 
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Brand Name
RAY THREADED FUSION CARE DEVICE
Type of Device
RAY THREADED FUSION CARE DEVICE
Manufacturer (Section D)
SURGICAL DYNAMICS
MDR Report Key3885758
MDR Text Key4675308
Report NumberMW5036681
Device Sequence Number1
Product Code MAX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date10/10/2000
Device Model NumberA02003530091
Device Catalogue NumberS0499-01
Device Lot NumberK8L20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age39 YR
Patient Weight78
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