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

Catalog Number	45440005540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Fluoroscopic images show instrumentation from l4-s1, one of the s1 screw is fractured.Date of implant and revision are unknown, fusion status is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that post-op, screw head was broken off from the body of the screw.The surgeon was unable to ex-plant the entire screw and as such just removed the screw head before placing a parallel screw in the same vertebrae.Revision procedure took place and the broken aspect of the screw head was removed and a rescue screw was placed.Patient complications were reported unknown.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
No further patient harm was reported by the surgeon besides the revision surgery.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the screw has broken about 3 threads down from the head of the screw.Microscopic inspection of the screw revealed a fairly flat fracture surface with no indication of pre-failure.This type of damage is consistent with torsional overload during the removal process if information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON ESSENCE 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: 8347464
• Report Number: 1030489-2019-00164
• Device Sequence Number: 1833376
• Product Code: KWP
• UDI-Device Identifier: 00643169428775
• UDI-Public: 00643169428775
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 45440005540
• Device Lot Number: H5330797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 02/18/2019; 12/16/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 03/14/2019; 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention