MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SOLERA 5.5/6.0; ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION

Model Number 1556300500

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog #: 1555000500, 510k with #: k113174 is marketed in the united states.Device has been returned and analysis is anticipated.A follow up report will be sent when analysis is completed.Radiographic image review for post- op x-rays ap (anterior- posterior) and lateral, and a single sagittal ct image are provided.The fusion construct is reported as l5 to s2 ai.On the lateral x-ray, several of the set- screws appear to be out of the tulip heads.An l5- s1 interbody graft is present, one of the rods is fractured at l5- s1.Fusion status is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a rod and screw for a tlif (l4/5,l5/s)+ psf (l3/4).It was reported that the rod between right l5 and s broke.The rod broke and there was no fragment of the rod remaining in the patient's body.The nuts at left l3, s1 and s2ai backed out.There were no patient symptoms or complications as a result of the event.The pre-op diagnosis was protracted bone fusion.The levels implanted were l3-s2ai.There was no delay in overall procedure time/ in- patient or prolongation of existing hospitalization.Additional surgery was performed as replacement of rod was performed, and the rod was reinforced.Date of initial surgery was (b)(6) 2018.The mdt products used in initial surgery were so56+gc.No health damage in the patient was reported.All products were explanted.All products were replaced by medtronic products.The patient's medical history included hypertension.No further complications were reported/ anticipated.

Manufacturer Narrative

B1, b2: updated adverse event/ product prob and outcome attributed to adverse event h3: product analysis part# 1556300500, lot# 0599084w- visual review confirms rod breakage.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.Significant deformation at multiple locations along the length of rods due to apparent rod bending.Microscopic examination of the fracture surface identified a fairly flat fracture surface with shear lips towards the end of the break indicating material overload.The above observations are consistent with bend stress overload.H6: updated patient code, eval.Code method, eval.Code result post analysis medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: CD HORIZON SOLERA 5.5/6.0
• Type of Device: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10501138
• MDR Text Key: 206118911
• Report Number: 1030489-2020-01228
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: N/ A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1556300500
• Device Catalogue Number: 1556300500
• Device Lot Number: 0599084W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 83