MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7191545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis: it was a trauma case so the surgeon performed fixation.It was reported that post-op, upper half of the broken screw has been explanted and lower half of the screw remained in vertebral body.Revision surgery was performed as a result of the event.
Additional Manufacturer Narrative
Product analysis results: visual and optical inspection confirmed the screw has broken about 4 threads down from the head of the screw and the broken half was not returned for inspection.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 SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7933241
• Report Number: 1030489-2018-01326
• Device Sequence Number: 1343884
• Product Code: KWP
• UDI-Device Identifier: 00885074465180
• UDI-Public: 00885074465180
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K043151
• 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,Followup
• Report Date (Section B): 07/08/2019

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 Expiration Date: 02/25/2020
• Device Catalogue Number: 7191545
• Device Lot Number: H5160964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Received by Manufacturer: 09/16/2018
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 07/08/2019
• 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
• Patient Age: 26 YR
• Patient Weight: 55