MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 1556300500

Device Problem Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 09/03/2021

Event Type  malfunction  

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.This device is not approved for sale in us but a similar device with catalog # 1556200500, 510k# k131321 and udi (b)(4) is approved for sale in us.This event is serious injury reportable.Since the device is not marketed in the us, the device is reported as a malfunction for a similar device.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider (hcp) via the manufacturer representative regarding an event which occurred post an initial t9/s2 psf l2/3 plif l4 pso procedures in a patient diagnosed with lumbar kyphosis.It was reported that the products explanted due to postoperative transverse process fracture.The hooks on both sides used for the t9 transverse process were removed.There was no malfunction with the hooks themselves.The cranial rods were too long and could almost be touched through the skin, so the rods were cut.There are no reports of defects or adverse events for the rod.Doctor cut 50 cm rods and use them, so there is no problem with the size of the rod as a product.It seems to be a problem when installing.The doctor intentionally cut a rod that was too long during the reoperation.No other patient injury / complication was reported.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: david gustafson ; 1800 pyramid place; memphis, TN 38132 ; 7635149628
• MDR Report Key: 12511253
• MDR Text Key: 272657274
• Report Number: 1030489-2021-01190
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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: 0801118W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2021
• 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
• Patient Age: 61 YR
• Patient Weight: 61