MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	G7540020
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: macroscopic and optical examination revealed thread crest/flank damage; this damage appears to have initiated near the start of the thread, and is evident around the damaged portion of the thread.Functional evaluation with a sample mas head found the set screw was unable to be fully engaged.The above observations are consistent with misalignment of the mas and set screw threads during construct assembly.X-ray review results: post-op x-rays for bony segment thoraco-pelvic fixation for kyphotic deformity shows displacement of rods from connectors bilaterally.The connection between the upper and lower segments of the instrumentation occurs at the apex of the kyphotic deformity.This is a natural place for hardware failure to happen if fusion has not occurred.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis: t10 fracture - thoracic kyphosis procedure used: arthrodesis levels implanted: t3 - s1 it was reported that post-op, due to breakage of the connectors and rods that prevented from fusion, the set screw thread damaged and as a result the patient suffered with pain.T3-sacrum arthrodesis, rod replacement, screw replacement and nut replacement were performed as a revision surgery.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8365231
• Report Number: 1030489-2019-00187
• Device Sequence Number: 19313489
• Product Code: KWP
• UDI-Device Identifier: 00613994143181
• UDI-Public: 00613994143181
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2019

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 Expiration Date: 11/02/2025
• Device Catalogue Number: G7540020
• Device Lot Number: 0608068W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/25/2019
• 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 Age: 67 YR
• Patient Weight: 55