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

Catalog Number	4540020
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Weakness (2145)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.X-ray review: post-op x rays for t12-l5 posterior spinal fusion showed several set screws out of the screw heads.Fusion status is unknown.The rods appear to be long and may be interacting with the sacrum as a potential reason for this failure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on an unknown date, post-op, the x-ray image provided showed break-off set screw out of the head of the screw which caused nerve root compression in two levels.Revision surgery was performed on (b)(6) 2018 to fix and replace the three failed screws, two rods and ten set screws.Patient had lower limb weakness and no disability.

• 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: 7321643
• Report Number: 1030489-2018-00332
• Device Sequence Number: 152155
• Product Code: KWP
• UDI-Device Identifier: 00643169428898
• UDI-Public: 00643169428898
• Combination Product (Y/N): N
• Initial Reporter Country: SY
• PMA/510(K) Number: K142591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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: 4540020
• Device Lot Number: H5202806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/07/2018
• 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: Other; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 80