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 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that patient underwent transforaminal lumbar interbody fusion (tlif) with posterior fixation.During surgery, there was an audible pop sound and the tower came off.The screw and the tower at l5 were then replaced with new ones.Then both the persuaders were reduced down to 4mm.The s1 set screws were engaged but the l5 set screw would not engage so persuader was reduced to just a 1 mm more and this is when the tower popped off of the screw again, but just on one side.At this point, the l5 screw was switched, tlif was completed and screws and a rod were put on the patients left side with no further issues.The product came in contact with the patient.No patient complications were reported as the result of the event.

Manufacturer Narrative

Additional info: (b)(4) we do not know which one contributed to the reported event.So both the lot# are sent.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: it is possible that with excessive force the extender could be popped off the head.During normal use, the extenders would appear to function properly.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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7224665
• MDR Text Key: 98533532
• Report Number: 1030489-2018-00128
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169177048
• UDI-Public: 00643169177048
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 01/30/2018; 03/19/2018
• Supplement Dates FDA Received: 02/26/2018; 04/18/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 67 YR
• Patient Weight: 91