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

Catalog Number	75446540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review: post-op x-rays for l4-s1 tlif shows fractured sacral screw after a fall 4.5 years after surgery.There appears to be a paucity of bone in the l5-s1 disc space.Failure of bony fusion would contribute to this.Ct of the lumbar spine would be useful to see if bony fusion was complete.
Event or Problem Description
Pre-op diagnosis: previous l4-s1 tlif procedure: l4-s1 transforaminal lumbar interbody fusion(tlif) levels involved: l4-s1 it was reported that on an unknown date, post-op, patient reported a fall to the surgeon with pain.X-ray conducted on (b)(6) 2016 showed two broken screws.Hence, screw was explanted in a revision l4-s1 fusion surgery.
Additional Manufacturer Narrative
Product analysis: visual review confirms screw breakage approximately 1 thread down from the base of the bone screw head.Optic al and microscopic 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.Fracture surface damage is noted.Microscopic examination of the fracture surface identified a fairly flat fracture surface with multiple ratchet marks near the area of crack propagation, and gently convex progressive striations through the cross-sectional area of the bone screw, consistent with cyclic fatigue.Dimensional examination of the major diameter of the bone screw confirms relevant bone screw dimensions are within print specification.The above observations are consistent with cyclic fatigue.

• Brand Name: CD HORIZON
• 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: 6375599
• Report Number: 1030489-2017-00456
• Device Sequence Number: 500563
• Product Code: KWP
• UDI-Device Identifier: 00885074134116
• UDI-Public: 00885074134116
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 07/27/2017

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: 75446540
• Device Lot Number: H11L3055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: 07/27/2017; 07/27/2017
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 08/10/2017; 09/06/2017
• 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: 68 YR
• Patient Weight: 62