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

Catalog Number	8590855
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
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
It was reported that the patient was pre-operatively diagnosed with l4/5 segmental disc herniation, spinal stenosis and underwent lumbar decompression and bone graft fusion.During the surgery, the screw slipped during the screw insertion process.The product came in contact with the patient.No patient symptoms or complication were reported as result of this event.
Additional Manufacturer Narrative
Device evaluation: product analysis: visual and macroscopic inspection confirmed the set screw was returned with the top break off half separated from the lower threaded portion.It appears the break off screw was tightened causing the break off portion to separate which is consistent with the correct function of the screw.Inspection of the screw surface and threads did not identify any non-conformance.Root cause is undetermined why the screw was sent back.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: 8117952
• Report Number: 1030489-2018-01583
• Device Sequence Number: 1771070
• Product Code: KWP
• UDI-Device Identifier: 00721902365263
• UDI-Public: 00721902365263
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/14/2019

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: 8590855
• Device Lot Number: H5319925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR