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 Migration or Expulsion of Device (1395)

Patient Problems Necrosis (1971); No Code Available (3191)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) (revision surgery).Neither the device nor applicable imaging films were returned to manufacturer therefore cause of event cannot be determined.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.

Event Description

It was reported that on (b)(6) 2016 (date is approx.), post-op, l4 burst fracture was observed after 3+3 fixation.The rod was deviated at rear because (3 vertebral body) total six screws at cranial side were dislocated at rear.Six screws at caudal side ((b)(6)) from diseased vertebral l4 did not loosen so the surgeon did not perform screw reinsertion.Necrosis was found at l1 the most cranial side and the surgeon performed only cleaning without screw reinsertion.4 screws ((b)(6)) were reinserted instead of l2((b)(6)) and l3((b)(6)) also 190 mm rod was placed at right and 180 mm rod was placed at left in the patient.The cause of dislocated screw was that patient bone quality was not good so there was no fixed power in the bone.At the surgery, the surgeon performed to open the incision in minimum due to necrosis.Also surgeon aimed at sufficient fixing force reinforcement with ha stick after removing screws.

Manufacturer Narrative

X-ray review: "post-op x-rays from stabilization of a lumbar deformity show screw pull out at multiple levels above fracture.There is lumbar kyphotic deformity, bone quality is poor.Instrumentation appears undersized, and the rod contour appears wrong, possibly contributing to pre load on screws.Root cause surgical technique and patient factors." 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 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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5619154
• MDR Text Key: 43983413
• Report Number: 1030489-2016-01216
• 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: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2023
• Device Catalogue Number: 54750017540
• Device Lot Number: H5208781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR