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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Suspect medical devices: the following products were used in the surgery.Some of the following parts are not approved for use in the united states; however their similar devices have been cleared for sale in the united states.These similar parts have been mentioned in the brackets.Product id: 779325555, qty: 5.(similar product: 779125555, 510(k): k101074, udi: (b)(4)).Product id: g869h021, qty: 2.(similar product: 869-021, 510(k): k040962, udi: (b)(4)).Product id: 7078396, qty: 2.(similar product: 5440030, 510(k): k102555, udi: (b)(4)).Product id: 4986045, qty: 2, 510(k): k133205, udi: (b)(4).Product id: g7753807, qty: 2, 510(k): k180851, udi: asku.Product id: 5530030, qty: 2.(similar product: 5440030, 510(k): k102555, udi: (b)(4)).Product id: 5531415, qty: 1, 510(k): k150178, udi: (b)(4).Product id: 55740005530, qty: 1.(similar product: 55840005530, 510(k): k113174, udi: (b)(4)).Product id: 55740005535, qty: 2.(similar product: 55840005535, 510(k): k113174, udi: (b)(4)).Product id: 55740006530, qty: 1.(similar product: 55840006530, 510(k): k113174, udi: (b)(4)).Product id: 55740006535, qty: 3.(similar product: 55840006535, 510(k): k113174, udi: (b)(4)).Product id: 55740006540, qty: 2.(similar product: 55840006540, 510(k): k113174, udi: (b)(4)).Product id: 55740006545, qty: 4.(similar product: 55840006545, 510(k): k113174, udi: (b)(4)).Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent posterior lumbar fusion and fixation at t6-l3 due to kyphosis.After approximately one week post-op, patient had fever.When evaluation was performed, infection was found.Hence, a revision surgery was performed for the removal of all implants on (b)(6) 2019.New implants were inserted during the revision surgery.No malfunction with any of the implants was alleged which could have led to infection.The severity of the infection was determined to be not serious.Allegedly, the patient has still not recovered.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8531049
• MDR Text Key: 142469440
• Report Number: 1030489-2019-00441
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention