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

Catalog Number	7225545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Increased Sensitivity (2065); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
Procedure: posterior lumbar interbody fusion levels: l4-5, l5-s1 it was reported via a medwatch form that the patient underwent a posterior lumbar interbody fusion with a wide decompression and posterior instrumentation with pedicle screw and rod systems.Post-op, the patient complained of continuous pain and tenderness of lumbar spine.The patient underwent ct which showed that the back had not fused after the surgery and he had two broken pedicle screws at s1.The patient underwent removal of hardware.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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: 6253047
• Report Number: 1030489-2017-00118
• Device Sequence Number: 1027144
• Product Code: KWP
• UDI-Device Identifier: 00885074362762
• UDI-Public: 00885074362762
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2016

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: 7225545
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2016
• Supplement Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 55 YR
• Patient Weight: 121