MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN BONE MORPHOGENETIC PROTEIN; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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

Patient Problems Rheumatoid Arthritis (1724); Pain (1994); Swelling (2091); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Procedure performed: transforaminal interbody fusion at l4-l5, l5-s1.Post-op, on (b)(6) 2009, the patient experienced excessive swelling at the surgical site and increased leg pain.In 2011, patient experienced rheumatoid symptoms resulted in widespread nerve and muscle pain.In 2014-15, widespread nerve and muscle pain increases because of that patient experienced lumbar/ sacral/ coccyx / left sided groin pain left leg radiculitis and neck pain.Eventually.Mri/ct exams identified a displayed disc with surrounding bones at l4-l5.Patient had discectomy in 2015.Patient orthopedic md reported, patient had to microscopically remove the bone growth, the growth was found to be indenting patient l5 nerve root.In 2020 patient continued to had lumbar and cervical pain ,arm pain, left leg radiculitis and left foot contraction.Patient could not sit or stand for more than 15 to 30 minutes.Patient has to reposition in every 15 minutes patient faces many sleepless nights and trouble while concentrating.Patient rheumatoid since 2011 had been interesting most recently patient rf was high, patient rheumatoid diagnosis was lupus in 2011.And now it changed to undifferentiated and makes connective tissue disease patient believed bmp caused patient body greatly harm and it disabled the patient.

• Brand Name: UNKNOWN BONE MORPHOGENETIC PROTEIN
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10232317
• MDR Text Key: 197558708
• Report Number: 1030489-2020-00827
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability