MAUDE Adverse Event Report: UNKNOWN MICRO PITUITARY; RONGEUR

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Nerve Damage (1979); Pain (1994); Deformity/ Disfigurement (2360); Spinal Cord Injury (2432); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 11/15/2019

Event Type  Injury  

Event Description

(b)(6) neurosurgeon, november i was having a disc in my back removed it should have been a 45 min surgery but the dr broke 2 tools in my back and had to open the other side of my back to find them and after 2 and a half hours he found them but ended up messing up the right side of my back and all my leg with nerve damage to my spine cord.It wasn't even the side he was working on.So just learning things all over again.I've already realized that i will now have to live with this but i'm going to build my back and leg as much as i can.It's painful.I suffer from sexual dysfunction due to the nerves and my hip and buttocks are now have deformities that hurt with thick nerves bulging from behind my hips and buttocks, i can't sit, stand, walk use the restroom or shower properly or drive a vehicle safely.These were the hospital's tools but i don't know if these tools reported, the dr said he red taped them and the hospital specifically told him they were going to just repair them.It's been almost 9 months and i'm still so far from normal, i may now need a fusion put in place to help me out for the future, i'm a mother of 3 and wife who drove for work and now my life is turned upside down.Please help me.It was two separate tools broken in my back.Fda safety report id #: (b)(4).

• Brand Name: MICRO PITUITARY
• Type of Device: RONGEUR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10326493
• MDR Text Key: 200812770
• Report Number: MW5095737
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/23/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 34 YR
• Patient Weight: 84