MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON® SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	6430530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
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
It was reported that the patient was pre-operatively diagnosed with stenosis and underwent oblique lumbar interbody fusion (olif) surgery at l4-5 levels.During surgery, the set screw at l5 idled at the final tightening.The product came in contact with patient.There was a delay of less than 60 minutes as a result of this event.The product came in contact with the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: macroscopic and visual 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 bone screw head found the set screw was unable to be fully engaged.The above observations are consistent with misalignment of the bone screw head and set screw threads during construct assembly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 7989084
• Report Number: 1030489-2018-01385
• Device Sequence Number: 1214202
• Product Code: NKB
• UDI-Device Identifier: 00643169545281
• UDI-Public: 00643169545281
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2025
• Device Catalogue Number: 6430530
• Device Lot Number: 0593591W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1