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 Disassembly (1168)

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

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that patient underwent one above and one fixation for l1 burst fracture along with correction using sas trauma device for kyphosis.Intra-op,when the rod was being placed, left extender at l2 came off from the screw.The extender was tried to reattach to the screw, but it did not work.So, the screw was removed once and it was replaced using another extender.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: product analysis : visual and optical examination of the mas head engagement features display significant deformation and damage at the mas retention features.The event description suggests that the extenders may have been fully reduced individually.The surgical technique advises against this, stating ¿it is important to reduce the rod in stages.The complete reduction of one extender without reducing the others will cause the rod to put a strong force on the other extenders, which can 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 been damaged during the surgery which is referenced in this complaint.The above observations are consistent with overload of the extender mas head engagement features.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: 6492538
• MDR Text Key: 72800643
• Report Number: 1030489-2017-00812
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169177055
• UDI-Public: 00643169177055
• 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: 07/20/2017

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: 7578302
• Device Lot Number: EM14M009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: 07/20/2017; 07/20/2017
• Supplement Dates FDA Received: 07/21/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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: 19 YR