MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 7570905

Device Problem Sticking (1597)

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

Event Date 03/31/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown spinal procedure at l3.During the procedure, "the extender was unable to reduce past 8mm.Doctor tried unreducing the reducing with all other extenders but still it jammed at 8mm.It then came off the screw and the surgery had to be completed as open surgery at that level to ensure that the rod was fully seated.A larger incision was made to enable seating of the rod at this level." no patient complications were reported.

Manufacturer Narrative

(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.

Manufacturer Narrative

Product analysis: the inner sleeve is bent on one side near the tip.The bend appears to the result of overload possible from positioning the screw.Because of the bend the positional relationship between the locating tabs on the tip of the sleeve has changed this could cause the sleeve to become stuck to the bone screw.Conclusion: the above observations are consistent with bend stress overload.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 4664760
• MDR Text Key: 5733388
• Report Number: 1030489-2015-00721
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K052747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7570905
• Device Lot Number: FA13E011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1