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

Catalog Number 6430530

Device Problems Material Fragmentation (1261); Metal Shedding Debris (1804); Failure to Align (2522); Appropriate Term/Code Not Available (3191)

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

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).(thread damaged), (burr).Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that patient underwent tlif and plif surgery at l3-s1 (l3/4: tlif, l4/5: plif, l5/s: tlif).During the surgery, both sides l5 set screw was stripped and it could not be tightened during final tightening.The surgeon checked it in the out of surgical field and it was found that the thread of set screw was damaged.Burrs left in the surgical field and they were removed.A surgeon decided to break the tab first and then perform final tightening because excessive force was loaded to the connect part of screw head and the tab due to the alignment was bad.The surgeon broke the tab as he said and he performed final tightening with a counter.The surgeon considered twist might be occurred at transition of a screw head and a tab in the cases which reverse direction of the force is applied to a screw and a tab or bad alignment.The set screw could not be withstood the force.The surgical time was extended for 31-60 min.The set screws were overloaded when right and left set screws at l5 were temporary tightened.Both screws were rounded off at the time of final tightening so they were replaced for few times.The burrs were disposed at the hospital.

Manufacturer Narrative

Product analysis: visual examination of set screws identified thread damage and rod contact surface deformation consistent with thread overload during attempted in vivo construct assembly.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5506575
• MDR Text Key: 40831254
• Report Number: 1030489-2016-00710
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143375
• 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,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2023
• Device Catalogue Number: 6430530
• Device Lot Number: 0385355W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• 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