MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	54840007545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2016
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.
Event or Problem Description
Pre-operative diagnosis: adjacent level herniated disc levels implanted: l5-s1 it was reported that during surgery, when surgeon went to remove set screws and rods, one of the screw head broke off.Adjacent level surgery was performed with additional hardware.Part of broken pedicle screw still remains in patient at s1.No patient complications as a result of this event.
Additional Manufacturer Narrative
Product analysis: visual review confirms screw breakage at the bone screw neck.Microscopic examination of the area immediately adjacent to the area of fracture origination identified a witness mark on the chamfered area of the mas head and material deformation just below the fracture surface, which may have contributed to the foregoing event.Microscopic examination of the fracture surface identified significant damage and smearing.Microscopic examination of the undamaged portion of the fracture surface identified a fairly flat fracture surface with gently convex beach marks and progressive striations through the cross-sectional area of the bone screw neck.Unable to determine root cause due to evidence which could support multiple conclusions.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6269215
• Report Number: 1030489-2017-00134
• Device Sequence Number: 844634
• Product Code: NKB
• UDI-Device Identifier: 00613994589293
• UDI-Public: 00613994589293
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2017

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: 54840007545
• Device Lot Number: H12B4490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided; 02/14/2017
• Initial Report FDA Received Date: 01/23/2017
• Supplement Report FDA Received Date: 02/21/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1