MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 1556300500

Device Problems Migration (4003); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

510(k) for similar product marketed in us with catalogue # 1476200500 is k132111.Evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of traumatic vertebral fracture (3 vertebral bodies of l1.L2.L5).It was reported that after the procedure the set screws on both sides of the fixed lower level(s2)had loosened, according to the image, the rod had moved.Product remains implanted in patient.The loosening was suspected and confirmed on july 27.It was very probably that it occurred immediately after walking and sitting on the bed were allowed at about 2 weeks after operation.There were no patient symptoms or complications as a result of this event.Bone graft had not been performed because it was a trauma, and ps was not inserted in s1, and ballast had been inserted in s2ai.Ins trumentations were th10,11,12,l1,2,3,4 and 5, anchor had been inserted in s2ai, and bone graft had only been performed at l1,2,3.An additional operation was performed on august 5.The backing out and loose of the set screw occurred, but it was unknown whether the event was caused by screw or set screw.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10500866
• MDR Text Key: 222287592
• Report Number: 1030489-2020-01221
• 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: Other
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1556300500
• Device Catalogue Number: 1556300500
• Device Lot Number: 0718992W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR