A JACKSON SPINAL TABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for A JACKSON SPINAL TABLE manufactured by Mizuho Orthopedic Systems, Inc..

Event Text Entries

[109661862] I had 15-s1 plif, and immediately had pelvic pain. I recently went to dr. (b)(6). He said i was injured from the operating room table during my surgery. I had my plif at (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077515
MDR Report Key7553243
Date Received2018-05-29
Date of Report2018-05-26
Date of Event2007-12-17
Date Added to Maude2018-05-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameA JACKSON SPINAL TABLE
Generic NameTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES
Product CodeJEB
Date Received2018-05-29
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMIZUHO ORTHOPEDIC SYSTEMS, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2018-05-29

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