MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 54740006545

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Pms/510k: this part is not approved for use in the united states; however a like device catalog # 54840006545, 510k # k091974 and udi # (b)(4) was cleared in the united states.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 the patient had undergone l3-l5 posterior lumbar interbody fusion.On an unknown date, post-op, the alleged screw cut out the pedicle at one side of l3.Along with the alleged screw, the cage (from another manufacturer) backed-out.It is considered that bone union had not been achieved because of back out and cut out.Hence, a revision surgery was scheduled for (b)(6) 2020.But just before the revision surgery, it was postponed due to sudden change in patient's physical condition.So, the revision surgery was performed on (b)(6) 2020.The screws and rods, that had been implanted, were all removed, and thicker screws were inserted while changing the trajectory again, and the fixation range has been extended both upward and downward.Paralysis had occurred to the patient, but the surgeon considered that the cage (of another company), which had been implanted, had deviated greatly inside the spinal canal, which could be the cause.In the revision surgery, an attempt was made to remove the cage, but the cage was located on the ventral side of the dura and it was judged to be impossible to remove the cage.The cage remained in the original state.On (b)(6) 2020, oblique lumbar interbody fusion was performed at l2-l4.

Manufacturer Narrative

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

Event Description

On (b)(6) 2020: olif was performed at l3-l5 (not l2-l4).The sales rep reported that the alleged screw might have been discarded at the hospital.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9915026
• MDR Text Key: 188467950
• Report Number: 1030489-2020-00407
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54740006545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2020
• 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): Required Intervention
• Patient Age: 83 YR