MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 55740006540

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem Neuropathy (1983)

Event Date 04/22/2021

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

Information was received from healthcare professional via field representative regarding patient with symptoms of l4 burst fracture involved in spinal therapy.Levels implanted- l2/3/5/s.It was reported that post-op, radicular symptom of l5 was reported in the patient.Scheduled to perform replacement for april 27 because of s screw was deviated to lateral.Product was used correctly according to the directions given in the ifu/labeling.On (b)(6) 2021 , received additional information that after the operation, radicular symptom appeared, and when checked, the screw had deviated from the pedicle.Reoperation for reinsertion was scheduled.It was recognized as technical error on (b)(6) 2021 , received additional information that s screw was deviated and malpositioned.The s screw deviated at sacrum level.R eported event was a user error.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via field representative regarding patient with symptoms of l4 burst fracture involved in spinal therapy.Levels implanted- l2/3/5/s.It was reported that post-op, radicular symptom of l5 was reported in the patient.Scheduled to perform replacement for (b)(6) because of s screw was deviated to lateral.Product was used correctly according to the directions given in the ifu/labeling.On 2021-apr-22, received additional information that after the operation, radicular symptom appeared, and when checked, the screw had deviated from the pedicle.Reoperation for reinsertion was scheduled.It was recognized as technical error on 2021-apr-28, received additional information that s screw was deviated and malpositioned.The s screw deviated at sacrum level.Reported event was a user error.On 2021-may-19, received additional information from the representative that, screw that was originally inserted was removed and reinserted in a new insertion direction.The procedure seemed to be posterior lumbar fusion (plf).The screw that was inserted was 7.5 mm in diameter.It was thought that the length was probably 40 mm.The physician made a mistake in the insertion direction or it was pushed by the muscle and changed direction.The patient status was unknown on 27-april-2021.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11826608
• MDR Text Key: 252412761
• Report Number: 1030489-2021-00619
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55740006540
• Device Catalogue Number: 55740006540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 06/14/2021
• 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; Required Intervention