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

Catalog Number	70460500
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: after visual and optical examination, it appears that threads of the screw are cross-threaded/damaged.This damage appears to have initiated at the start of the thread and is consistent around the damaged portion of the thread.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-op diagnosis: adult deformity levels involved: pelvis it was reported that intra-operatively, threads in the screw head was noted to be strange.During the surgery, when the screw was placed in the usual fashion, upon attempting to insert a set screw, the set screw would not engage.The surgeon attempted to use a different set screw but encountered the same result.At that point the surgeon chose to remove the screw and inspect, upon visual inspection he noted that the threads inside the head of the screw looked strange.The screw was then set aside and another screw was implanted.The set screw would not engage to although threads were present.The product came in contact with the patient.Breakage of product was not observed.No patient complications were reported as a result of the event.

• 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: 8721116
• Report Number: 1030489-2019-00654
• Device Sequence Number: 1684673
• Product Code: KWP
• UDI-Device Identifier: 00613994156617
• UDI-Public: 00613994156617
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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 Catalogue Number: 70460500
• Device Lot Number: W07L4109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR