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

Catalog Number	7578301
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2017
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem 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.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7439118
• Report Number: 1030489-2018-00569
• Device Sequence Number: 16430724
• Product Code: NKB
• UDI-Device Identifier: 00643169177048
• UDI-Public: 00643169177048
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K122862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 7578301
• Device Lot Number: EM15G033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 91