MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 5484902

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Event Description

It was reported that the patient underwent "l3-s: pps s2: posterior spinal fusion" due to lumbar degenerative spondylolisthesis.During surgery, when the surgeon tried to place a screw provisionally, shaft of extender and shaft of a screw were misaligned.So it was spinning and making some noise inside.Consequently, the thread of the set screw was damaged.Right s1 set screw idled with a sound during tightening.The set screw was inserted in misalignment with the extender and it probably caused the event.Metal fragment(s) was generated and disposed at the hospital.No fragments of the products remained inside the patient.Also, sl sequential reducer made some noise and was broken during placing a rod.Inner sleeve and outer sleeve got separated during pushing down a rod.The reducer was replaced with other.The sequential reducer came in contact with the patient.No patient complications were reported.

Manufacturer Narrative

Product analysis: visual review confirms instrument disassembly.Visual review of the -01 reduction sleeve identified material deformation on the adjacent side of the sleeve, consistent the off-axis reduction of the associated rod.Microscopic examination of the -05 retaining ring identified axial shear lines along the top and bottom corners of the outer diameter surface of the ring.Witness marks and deformation in ring groove and on the ring itself suggest the retaining ring was initially seated in the ring groove.Dimensional examination of the -02 reducer body groove diameter, (into which the -05 retaining ring is seated), as well as the -05 retaining ring material thickness of the ring was found to be within print specification.The od of the -05 retaining ring found to be undersized the above observations are consistent with manufacturing issue.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.

Manufacturer Narrative

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): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5627032
• MDR Text Key: 44349527
• Report Number: 1030489-2016-01281
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122862
• 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: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5484902
• Device Lot Number: EM14M037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR