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

Catalog Number	7191545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product is not returned to manufacturer for evaluation.However x-ray images were submitted which reveals: "post op x-rays show questionable fracture of at least one of the l5 screws on an l1-5 posterior spinal fusion.Placement appears appropriate and this should not cause neural compression as the screw has not violated bony cortical margins.It is not possible to determine extent of bony fusion on images provided." a good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Procedure: "t/l open" it was reported that post-operatively screws were broken inside the patient due to which nerve roots are getting compressed.As a result of this patient was having severe back and leg pain.Broken screws were explanted partially (80% of screws remains inside patient) and four screws were used for fixation.
Additional Manufacturer Narrative
Product analysis :visual review confirms screw breakage ~2 threads down from the base of the bone screw head.Visual 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 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6515073
• Report Number: 1030489-2017-00964
• Device Sequence Number: 10984127
• Product Code: KWP
• UDI-Device Identifier: 00885074465180
• UDI-Public: 00885074465180
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K043151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/17/2017

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 Expiration Date: 02/19/2020
• Device Catalogue Number: 7191545
• Device Lot Number: H5160821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided; 06/19/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 06/23/2017; 10/17/2017
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 58