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

Model Number 5542360

Device Problems Mechanical Problem (1384); Device Slipped (1584); Material Deformation (2976)

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

Event Date 08/25/2020

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 degenerative disc disease involved in l3-s1 tlif and bilateral sij fusion.It was reported at the end of the procedure, when they were breaking off the gold set screw using the appropriate driver, the set screw did not give the usual crisp breaking sound, instead it just quietly slipped off.Set screw was not torqued correctly so, they attempted to remove the set screw.They were unable to remove the set screw using the hex driver in the prolock crosslink tray so, a set screw extractor was used from the universal set screw removal tray.They were still unable to remove the set screw set.Later, they attempted to remove the entire rod construct on that side which consisted of removing already broken off set screws.Upon removal of the rod and crosslink, the crosslink was still unable to be removed from the rod.Reported there was no problem with hex driver.Additional surgery was performed, as they had to remove a crosslink that was already insitu, set screws already insitu and a rod already insitu.They couldn t get the crosslink off the rod, so a new rod had to be cut and bent.New solera 5.5 set screws and new crosslink was used.Surgical delay was approximately 1 hour.No other harm to patient.No fragments left in patient.No further surgery required/ scheduled.Procedure was completed without incidence.After, completing the procedure, failed cross link and rod was inspected.Reported, they were able to remove the crosslink by sliding it off the end of the rod, that was very tight.Reported, the set screw found to be broken off at the correct spot.However, the set screw also found to have sheared through the threaded portion, as it just fell out of the crosslink when removed from the rod.There were no patient symptoms or complications reported as a result of this event.Patient is alive and no injury.

• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10552595
• MDR Text Key: 207509253
• Report Number: 1030489-2020-01302
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153589
• 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
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5542360
• Device Catalogue Number: 5542360
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• 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
• Patient Age: 37 YR
• Patient Weight: 123