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

Catalog Number 7049855

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem Pain (1994)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

No product and product images were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that, patient complained of pain due to which the patient wanted the screw to be removed.For which the patient underwent explant surgery on (b)(6) 2017.The set screw did not unscrew as being cold welded to the connector and metal cutting burs were used to cut the construct to remove the iliac screws.Patient issue has been resolved now.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 6881815
• MDR Text Key: 86839851
• Report Number: 1030489-2017-02087
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00613994171108
• UDI-Public: 00613994171108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7049855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention