MAUDE Adverse Event Report: HARRINGTON RODS; GROWING ROD SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 03/04/2000

Event Type  Injury  

Event Description

I have severe pain and mental anguish from having this surgery and it's effecting my life greatly.Any help would be greatly appreciated.

Event Description

Additional information received from reporter on 07-nov-2023, for mw5147416.Scoliosis surgery on (b)(6) 2000.I have bulging discs, deteriorating dics, pinched nerves, pain in every joint, twitching in eyes and muscle, swelling aka (as known as) edema, pain in chest, arthritis and popping in chest wall.(b)(6) clinic, dr.(b)(6).

• Brand Name: HARRINGTON RODS
• Type of Device: GROWING ROD SYSTEM
• MDR Report Key: 18031376
• MDR Text Key: 326947530
• Report Number: MW5147416
• Device Sequence Number: 1
• Product Code: PGM
• 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,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: 4 TITANIUM SCREWS; INFLAMMATION MEDS; MIGRAINE MEDICINE; MUSCLE RELAXERS; PAIN MEDS
• Patient Outcome(s): Hospitalization; Disability; Other; Required Intervention; Life Threatening
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White