MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number UNK_SPN

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Injury (2348); Paraplegia (2448)

Event Date 04/01/2017

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2017 a patient was implanted with an oasys occipito-cervico-thoracic spinal system to support spinal fusion.In or around (b)(6) 2017, the patient began experiencing extreme pain and inability to stand and walk.In (b)(6) of 2018, the patient learned these issues were related to the device failure and underwent additional medical treatment, including an additional revision surgery to remove the occipito-cervico-thoracic spinal system.

Event Description

It was reported that on (b)(6) 2017 a patient was implanted with an oasys occipito-cervico-thoracic spinal system to support spinal fusion.In or around (b)(6)2017, the patient began experiencing extreme pain and inability to stand and walk.In march of 2018, the patient learned these issues were related to the device failure and underwent additional medical treatment, including an additional revision surgery to remove the occipito-cervico-thoracic spinal system.

Manufacturer Narrative

Corrections made to product code, common device name, and initial reporter type.Material analysis, visual, dimensional, and functional inspection could not be performed as the device was not returned.Complaint history records were not reviewed as a valid lot number was not provided and could not be obtained.Manufacturing history records were not reviewed as a valid lot number was not provided and could not be obtained.Additional information was not able to be obtained.The root cause of the reported event can not be determined as no device was received and insufficient information was provided for review.If devices and/or additional information become available, this investigation will be reopened.Hospital did not return device.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8656566
• MDR Text Key: 146618433
• Report Number: 3004024955-2019-00015
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• PMA/PMN Number: K151755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention