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

Catalog Number	55840018500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date: only year valid.Explant date: only year valid.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 on unknown date in 2017, the patient underwent l4-ilium fusion.On an unknown date, post-op, the screw broke.Hence, the patient underwent a revision surgery in which the broken screw was explanted.No fragment of the broken screw remained inside the patient.The patient had achieved solid fusion.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual review confirms screw breakage approximately 2 threads down from the base of the bone screw head.Visual and optical examination of the area of fracture initiation did not identify a pre-existing surface defect near the area of crack origination that could contribute to crack propagation.Significant fracture surface damage is noted near the area of crack propagation.Microscopic examination of the undamaged portion of the fracture surface identified a fairly flat fracture surface with gently convex progressive striations through the cross-sectional area of the bone screw, consistent with cyclic fatigue.This type of damage is 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: 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: 8936200
• Report Number: 1030489-2019-00948
• Device Sequence Number: 525780
• Product Code: NKB
• UDI-Device Identifier: 00643169075740
• UDI-Public: 00643169075740
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2019

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: 55840018500
• Device Lot Number: H5361027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 11/02/2019
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 72