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

Catalog Number	54840006540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with recurrent spinal stenosis with right leg pain, compression of cauda equina, grade 2 spondylolisthesis at l4-l5, severe spondylosis at l5-s1, degenerative spondylolisthesis, l4-l5, grade 2, prior laminectomy at l5 and underwent revision of a prior l4-s1 fusion.During removal of the implanted instruments, when removing the screw, the shaft of the screw completely fractured in half directly under the tulip head.It was then left with the threaded portion of the screw still inside of the patient and the tulip head was detached.The threaded portion of the right l4 screw and the threaded portion of both l5 screws remain inside of the patient.Instruments were found broken.The screw fractures first occurred upon removing the right l4 screw.Then after that fractured, there was an attempt to remove broken screws.1-2 additional operating hours added to the surgery time.
Additional Manufacturer Narrative
Visual review confirms screw breakage at the bone screw neck, just below the head.Visual and microscopic examination of the mas head identified witness marks and material deformation on the bottom face of the mas head, near the area of crack propagation.Dimensional examination of the bone screw neck orientation found to be near the maximum angulation of the head.These observations suggest possible loading the bone screw around the neck area of the bone screw.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.Microscopic examination of the fracture surface identified a partial 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 which is consistent with cyclic fatigue.The remaining fracture surface consist of shiny ridges that suggest surface smearing during breakage.Dimensional examination of the major and minor diameters of the bone screw confirm relevant bone screw dimensions are within print specification.The above observations are 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: 7854559
• Report Number: 1030489-2018-01217
• Device Sequence Number: 1981022
• Product Code: NKB
• UDI-Device Identifier: 00613994589309
• UDI-Public: 00613994589309
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 54840006540
• Device Lot Number: H5184183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR