MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SOL5.5/6.0

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

Report source.Country: (b)(6).Device evaluated by mfr: 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

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having th11-l5 psf, olif and tlif.The patient's medical history is dialysis, nephrotic syndrome, cushing's syndrome, and ht.It was reported that the patient presented top adjacent intervertebral disorders and the additional surgery was performed for the extension to about th4 using a connector on (b)(6) 2022. according to the physician, the information is only the extension to about max th4 due to the adjacent intervertebral disorder of the patient underwent initial olif in the first or second case.The four screws on th12 and l1 had been loose and were four out of the fixation from th12 to s1.The four screws were replaced and the screws were returned to the patient.The revision surgery was performed successfully and hook on th4, ps insertion on th5-th11,ps replacement on th12 and l1 and the rods from th4 to l1 and from l2 to s1 were connected by striker's angle connectors.The bone graft was performed with gr strips 20 cm and completed.The type of the procedure was postoperative fixation extension of kyphosis.There were no further complications reported regarding the event.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14390422
• MDR Text Key: 291624272
• Report Number: 1030489-2022-00463
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SOL5.5/6.0
• Device Catalogue Number: MSB_UNK_SOL5.5/6.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2022
• 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): Required Intervention
• Patient Sex: Male