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

Catalog Number	7575545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not 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
Levels implanted: l3-l4-l5 it was reported that post-op, patient reported continue back pain.Hence the doctor decided to continue fusion at lower level spine (s1).During the procedure doctor found that one of the l5 screw was broken right in the middle of the screw body.
Additional Manufacturer Narrative
Product analysis result: visual optical dimensional visual and optical examination of mas bone screw confirms breakage approximately 3 threads from the base of the bone screw head, optical examination identified a fairly flat fracture surface, with secondary (post-fracture) damage to the fracture surface, predominately around the periphery of the fracture surface.Undamaged areas of fracture surface revealed ratchet marks near the area of crack propagation and gently convex striations through the cross sectional area of the material, consistent with cyclic fatigue.Dimensional examination of the major and minor diameter verified conformance to print specification.The above observations are consistent with cyclic fatigue.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Radiological image review results: post-op / pre-revision x-rays for extension of fusion to s1 shows a possible fracture of one of the l5 screws in the pedicle.No interbody grafts are present.Fusion status is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Type of procedure: open lumbar procedure.

• 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: 8319354
• Report Number: 1030489-2019-00120
• Device Sequence Number: 13834786
• Product Code: KWP
• UDI-Device Identifier: 00885074030678
• UDI-Public: 00885074030678
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2019

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: 7575545
• Device Lot Number: H5305089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 04/02/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/12/2019; 04/19/2019
• 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: Other; Required Intervention
• Patient Weight: 90