MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON BALLAST SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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

Patient Problem Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

Outcome to adverse event: other: paralyzed.The following products have been used in the surgery: part# 25740018570; lot# ca17g088; 510k# k153442; udi# (b)(4); qty# 2.Part# 5430520; lot# 0293711w; 510k# k132328; udi# (b)(4); qty# 2.Part# 5530130; lot# h5368782; qty# 1.Part# 5530130; lot# h5380247; qty# 2.Part# 55740007535; lot# h5425920; qty# 2.Part# 7078397; lot# h5437149; qty# 1.Part# 779345555; lot# 0586800w; qty# 1.Part# g869h021; lot# 0642575w; 510k# mtf943; udi# (b)(4); qty# 1.It is unknown which of the above implants were responsible for the adverse events.Also, it is unknown whether these products caused or contributed to the reported event or not.We are filling this mdr for notification purpose.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

It was reported that on an unknown date post-op, patient has been paralyzed and unable to stand.Hence on (b)(6) 2019, the decompression fixation (the fixation this time, was the forth time.L1-s2ai) was performed because of the stenosis and the thoracic spondylotic myelopathy at t9-12.The fixation had been done before remained the same, and t9-11 and l1 was connected with the mrc close/open vertical connecting connector.

• Brand Name: CD HORIZON BALLAST SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9435491
• MDR Text Key: 175069456
• Report Number: 1030489-2019-01401
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• 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): Other
• Patient Age: 64 YR
• Patient Weight: 69