MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	55840009570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returned to manufacturer for evaluation therefore are unable to determine definitive cause of event.
Event or Problem Description
It was reported that patient underwent a revision surgery for rod revision at l1-l2,require rod change and rod connector.Patient already had implants in from t2-pelvis with several screws missing throughout the middle of the construct.Plan was to replace screws in the lower half of the patient with other screws,then add axial connectors to the existing upper construct and place screws on the lower half.Intra operative a tip of driver broke in the screw so he placed the small piece of rod into the screw, put a set screw back on to make the screw fixed, then placed the counter torque over the head or the screw to get the screw in.This was when the head of the screw broke.Part of the thread was sticking out so he cut it off with a burr so it was flush with the pelvis.Doctor did not place another screw in the pelvis on that side.
Additional Manufacturer Narrative
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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6105101
• Report Number: 1030489-2016-03145
• Device Sequence Number: 10938894
• Product Code: KWP
• UDI-Device Identifier: 00643169005365
• UDI-Public: 00643169005365
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2016

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: 55840009570
• Device Lot Number: H5231017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: 10/21/2016
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1