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

Catalog Number	55840007545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not 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 patient underwent l4-s1 fusion.Post op, the patient had pain as the screw was reported broken.As a result, a revision surgery was performed to explant the broken screw.No fragments remained in the patient.The patient achieved solid fusion.No patient complications after the revision surgery were reported.
Additional Manufacturer Narrative
X ray review: post op x-ray for l4-s1 fusion shows bilateral fracture of the sacral alar screws.There is also a sacral l5 screw crossing the disc space.Unable to judge fusion status on these films but was solid by report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: visual review confirmed that the screw broke ~3 threads down from the base of the bone screw neck.Visual and optical examination of the area of fracture initiation did not identify a pre-existing surface defect that could contribute to crack propagation.Microscopic examination of the fracture surface identified a fairly flat fracture, with ratchet marks near the area of crack propagation, and convex progressive striations through ~85% of the cross-sectional area of the bone screw followed by a sheer lip at the end of the fracture, consistent with cyclic fatigue.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: 7073930
• Report Number: 1030489-2017-02413
• Device Sequence Number: 13687868
• Product Code: KWP
• UDI-Device Identifier: 00643169004344
• UDI-Public: 00643169004344
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2018

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: 55840007545
• Device Lot Number: H5269691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/12/2018; 02/06/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 01/25/2018; 02/19/2018
• 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: 38 YR
• Patient Weight: 108