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

Catalog Number 7578301

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Device evaluation anticipated but not yet begun.

Event Description

It was reported that a patient underwent posterior spinal fusion for l1 and l5 burst fractures on (b)(6) 2015.During surgery when the surgeon tried to push the rod down at th12 at cranial side, an extender came off as he kept on tightening the sequential reducer though rd sign was already shown.He final tightened the set screw without connecting the extender.No patient complications were reported due to this event.

Manufacturer Narrative

Product analysis: visual and microscopic examination of the mas head engagement feature display significant deformation and damage at the top of the retention features.The surgical technique states ¿it is important to reduce the rod in stages.The complete reduction of one extender without reducing the others, or over-reduction, could cause the rod to put a strong force on the other extenders, which may cause difficulties when reducing the others.The foregoing deformation of the interface features may have reduced the mechanical strength of the interface, which could contribute to the foregoing event.It is noted that the extenders are a multi-use instrument, and may not have sustained the aforementioned damage from the associated surgical event.Conclusion: the above observations are consistent with overload of the extender mas head engagement features.

Manufacturer Narrative

Codes are already sent in the initial rr but we are sending it again as rr is not allowing to submit without these codes.

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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5206688
• MDR Text Key: 30701938
• Report Number: 1030489-2015-02927
• 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,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7578301
• Device Lot Number: EM13G003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 10/07/2015
• Supplement Dates FDA Received: 12/04/2015; 12/04/2015; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2015
• 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: 00050 YR