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

Catalog Number	75446550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
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 the patient underwent minimally invasive transforaminal lumbar interbody fusion.Post-op, the screw head and th read was found separated and broken.The product came in contact with patient.No fragments of the broken part remains in the patient.Patient complications were unknown.
Additional Manufacturer Narrative
Image review: pre-revision and post revision x-rays for thoraco lumbar stabilization construct provided.In two of the provided images, there appears to be broken screw at the inferior level of a construct around a burst fracture.Each of the screws is connected probably 2 degree to osteoporosis.The construct was revised to a corpectomy graft at the fracture level.Hardware failure was likely 2 degree to failure of fusion given osteoporosis.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: a visual review confirmed the implant is fractured between ~9 threads from the base of the bone screw head.Microscopic examination of the adjacent surface around the possible area of crack propagation did not identify material surface defect that could contribute to crack propagation.Fracture surface is damaged, likely due to repeated, the cyclic impact of the upper and lower portions of the bone screw, post-fracture.Undamaged areas of fracture surface revealed gently convex striations through the cross-section of the bone screw, 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: 7546507
• Report Number: 1030489-2018-00759
• Device Sequence Number: 19116149
• Product Code: KWP
• UDI-Device Identifier: 00885074134123
• UDI-Public: 00885074134123
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2018

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: 75446550
• Device Lot Number: H5359336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 06/29/2018; 11/07/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 07/27/2018; 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1