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

Catalog Number	7575540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision surgery.Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient underwent a sextant surgery in which screws were implanted at l5-s1.Post-op, the screws broke due to which the patient had back pain.On 07 feb 2017, a revision surgery was performed in which the broken screws were removed and replaced with 2 new screws.
Additional Manufacturer Narrative
Product analysis : visual review confirmed the implants are fractured between ~3-4 threads from the base of the bone screw head.Optical examination of adjacent surface around the possible area of crack propagation did not identify material surface defect that could contribute to crack propagation.Microscopic examination of the fracture surface severely damaged, likely due to repeated impact of the two portions of the bone screw post-fracture.Dimensional examination of the bone screw diameters confirmed conformance to print specification.Conclusion: inconclusive; the extent and severity of the fracture surface damage renders the parts unsuitable for microscopic analysis.
Additional Manufacturer Narrative
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® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6375347
• Report Number: 1030489-2017-00447
• Device Sequence Number: 1081697
• Product Code: KWP
• UDI-Device Identifier: 00885074030630
• UDI-Public: 00885074030630
• 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 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): 04/26/2017

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 Catalogue Number: 7575540
• Device Lot Number: 0307927W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided; 04/26/2017
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 04/28/2017; 09/29/2017
• 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: 40 YR
• Patient Weight: 84