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

Model Number	855-011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare provider via manufacturer representative regarding a patient with (b)(6) phase of the peak, complicated by paravertebral and epidural flow abscess as pre-op diagnosis.The patient had medical history of (b)(6) of bones and joints (b)(6).Chronic viral (b)(6) of minimal activity.The disease caused by (b)(6), manifestations of mycobacterial infection (b)(6) infection.It was reported that legacy rod broke.The rod was implanted on (b)(6) 2019.The product will not be returned as it is implanted.Patient reported pain as a result of the event.Revision surgery will be conducted for explant.There were no further complications reported.

• 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: 10343232
• Report Number: 1030489-2020-01006
• Device Sequence Number: 19033576
• Product Code: KWP
• UDI-Device Identifier: 00673978061825
• UDI-Public: 00673978061825
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K954645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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 Model Number: 855-011
• Device Catalogue Number: 855-011
• Device Lot Number: 0319078W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/30/2020
• 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: 35 YR
• Patient Weight: 61