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

Catalog Number	54840047555
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
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 underwent anterior lumbar interbody fusion (alif), then posterior screw fixation surgery due to unknown reason.Intra-op, while attempting to remove the screw by dropping a rod down the tulip <(>&<)> pin wheeling out, the screw head detached from the post.The post is still in the patient.There were no patient complications were reported due to this event.
Additional Manufacturer Narrative
Additional information received: product analysis results: visual review confirms screw breakage at the bone screw neck, just below the head.He threaded lower portion of the screw that broke off was not returned.Visual and microscopic examination of the mas head did not reveal any witness marks or material deformation on the bottom face of the mas head.The torx driver's tip has broken off and jammed into the female torx of the screw.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 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 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 SOLERA 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: 9178272
• Report Number: 1030489-2019-01144
• Device Sequence Number: 2592280
• Product Code: KWP
• UDI-Device Identifier: 00643169438323
• UDI-Public: 00643169438323
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K141494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2019

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: 54840047555
• Device Lot Number: H5392173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1