MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON X10 CROSSLINK; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	5442138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign report source: (b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via manufacturer representative regarding a patient with an indication of lumbar disc herniation in need of lumbar discectomy used in spinal therapy.It was reported that when the cross link was implanted, the tapered protrusion of the cross link broke and fell off, and the fixation of the cross link failed.There was a delay of less than 60 mins in overall procedure time reported.There were no patient symptoms reported.There were no fragments in the patient reported.There were no further complications reported regarding the event.

• Brand Name: CD HORIZON X10 CROSSLINK
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10452818
• Report Number: 1030489-2020-01148
• Device Sequence Number: 11441641
• Product Code: KWP
• UDI-Device Identifier: 00613994588463
• UDI-Public: 00613994588463
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

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 Model Number: 5442138
• Device Catalogue Number: 5442138
• Device Lot Number: 0573546W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR