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

Catalog Number 54750017540

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6) (b)(4).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.

Event Description

It was reported that patient underwent pps surgery with 4.75 for diffuse idiopathic skeletal hyperostosis (dish) at th7-l3 (5a-2b), (t12, l1: skip) on (b)(6) 2015.The placed length of the rod was long (260mm) but surgeon did not bend the rod enough.(sales rep recommended to bend the rod).During surgery, set screw was tightened forcefully with rod pusher during rod placement at caudal side.No screw loosening observed during procedure so final tightening was performed.Post-op, surgeon confirmed x-ray image and there was no problem.When rep visited the facility in the end of the year for post-op follow-up, the patient's post-op course was reported to be good and started rehabilitation.On unknown date post-op, right side l2-3 pedicle screw loosening was observed and the patient complained of root symptoms.Revision surgery was performed.Surgeon performed to open right side until transverse process base and cut rod which was placed at initial surgery using dt-saw, after that he removed pedicle screws at l2-3.Hook trial was placed at l2-3 and 2 domino connector was placed and also rod was measured.The surgeon placed rod after placement of lamina hook, provisionally fixed the rod and performed final tightening after compression.The surgeon commented the considered rod bending at the initial surgery might be insufficient that might have made him to place the rod by force.

• Brand Name: CD HORIZON SOLERA VOYAGER 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): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5418393
• MDR Text Key: 37714661
• Report Number: 1030489-2016-00444
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54750017540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• 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