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

Catalog Number 7578302

Device Problem Device Inoperable (1663)

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

Event Date 06/18/2014

Event Type  malfunction  

Manufacturer Narrative

Additional info: visual and optical inspection identified plastic deformation on the upper portions of two of the four extender mas head male interface features.The deformation of the interface features could have reduced the mechanical strength of the interface.Additionally, one of the extender tips appears to be bent outward to the point of breaking off the multiple tip components, with deformation on the inside of the mas head interface, consistent with lateral bending stress.The above observations are consistent with bend stress overload of the instruments.

Event Description

It was reported that the patient underwent an oblique lumbar interbody fusion at l2-5 to treat degenerative lumbar scoliosis.It was reported that the extender at l3-4 could not be removed.After a delay the surgeon was able to temporarily distract to the extenders and remove from the patient.No patient complications were reported.

Manufacturer Narrative

(b)(4): neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3938774
• MDR Text Key: 12223957
• Report Number: 1030489-2014-03246
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7578302
• Device Lot Number: EM13F022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2013
• 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
• Treatment: BONESCREW