HYDRABSORB PROSTHETIC CAGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-24 for HYDRABSORB PROSTHETIC CAGE manufactured by Unknown.

Event Text Entries

[1163905] I had a spinal fusion at l4-5 using hydrabsorb prosthesetic cage and danek m8 pedicle screws and rods. Post operatively i did fine until i started having pain in november of same year, in february i requested x-ray which showed hydrabsorb had dissolved as well as the complete fusion using my iliac crest ad cadaver bone. Screws did not hold up and l4-5 had collapsed and compacted on each other. I mentally could not go through surgery until 2008, because my legs got so weak i couldn't go up stairs or do normal daily activities, as well as constant pain and depression. I had to apply for disability which eventually was approved. I am a rn and initially i went back to work until i found out the fusion had collapsed, so my plans to continue working ended. When i had second surgery. Physician stated that hydrabsorb was an inferior product and hadn't been used for a long time. I could misunderstood, but i would like this product investigated as it has changed my life causing me a second serious surgery from anterior and posterior approach and i still have pain. I do have medical screws that were used, but no info on them.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5011825
MDR Report Key1411977
Date Received2009-06-24
Date of Report2009-06-24
Date of Event2005-07-06
Date Added to Maude2009-07-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHYDRABSORB PROSTHETIC CAGE
Generic NameHYDRABSORB
Product CodeOJB
Date Received2009-06-24
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2009-06-24

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