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

Catalog Number	7577550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
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 spinopelvine fixation surgery.Post-operatively, as the screw was being explanted, the screw was broken in the upper part.The shaft from the screw is still in the pelvic region of the patient.The product came in contact with the patient.The patient has achieved solid fusion.No patient complications were reported.The screw was being explanted since the patient had achieved fusion.
Additional Manufacturer Narrative
Product analysis: visual and microscopic inspection confirmed the screw has broken right below the retaining ring of the screw.The lower threaded portion was not returned.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.The bone screw has been angulated and will not return to the original position in the crown of the screw.Visual inspection also confirmed witness marks where the rod was seated in the saddle of the screw.The location of the fracture at the base of the connector head, the fracture surface angulation relative to the thread axis, absence of thread damage and direction of shear lines are consistent with torsional overload.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: 8402879
• Report Number: 1030489-2019-00244
• Device Sequence Number: 19313400
• Product Code: KWP
• UDI-Device Identifier: 00885074032115
• UDI-Public: 00885074032115
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 7577550
• Device Lot Number: H5322053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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: 54 YR
• Patient Weight: 60