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

Catalog Number	5440430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that on an unknown date, intra-op, set screw broke.The set screw was replaced.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis :visual and optical examination of the returned set screw identified a fracture at one of the break-off portion hex corners, and is splayed open, consistent with bend stress overload during attempted implantation.

• 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: 6203462
• Report Number: 1030489-2016-03514
• Device Sequence Number: 10995836
• Product Code: KWP
• UDI-Device Identifier: 00613994790729
• UDI-Public: 00613994790729
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2017

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: 5440430
• Device Lot Number: H5288472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2016
• Supplement Report FDA Received Date: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1