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

Catalog Number	7575300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.T.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent percutaneous transforaminal lumbar interbody fusion at l4-l5.Intra-op, after locking the rod on the implant holder, the rod at the end of the inserter (that pulls the rod to lock) broke.The breakage was under the lock key.No fragment of the broken instrument was found to be present inside the patient.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Product analysis: visual and functional inspection confirmed the arc rod of the rod inserter has been broken.The break occurred where the arc rod attaches to the screw/bushing of the rod release cam.This type of damage appears to be from excessive force applied to the rod release cam when in use.The tension screw may have been to tight causing the damage when the rod release cam was locked into place.Unable to loosen/tighten the tension screw as it appears to be jammed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9508542
• Report Number: 1030489-2019-01459
• Device Sequence Number: 1215624
• Product Code: KWP
• UDI-Device Identifier: 00885074445380
• UDI-Public: 00885074445380
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K051674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 7575300
• Device Lot Number: SV12J039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 12/21/2019
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1