MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 26; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 48811226

Device Problems Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/24/2018

Event Type  Injury  

Event Description

It was reported that a patient was revised to remove an anterior cervical plate because the spring bar had protruded outward into the patient's esophagus causing pain.The plate and screws were removed and replaced with another cervical plate.

Manufacturer Narrative

Method: x-ray review, labelling review, risk assessment.Result: the reported event was confirmed by the x-ray image review.The device was not returned, therefore, product evaluation could not be performed.Manufacturing files were not reviewed because no lot numbers were provided.Conclusion: the potential root causes include: poor surgical candidate or bone quality, excessive post-op activity by patient (not recommended by surgeon), patient does not follow surgeon instructions, patient over exerts.The exact root cause couldn't be established.Device not returned.

Event Description

It was reported that a patient was revised to remove an anterior cervical plate because the spring bar had protruded outward into the patient's esophagus causing pain.The plate and screws were removed and replaced with another cervical plate.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 26
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7796611
• MDR Text Key: 117566527
• Report Number: 0009617544-2018-00199
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152170
• UDI-Public: 07613252152170
• Combination Product (y/n): N
• PMA/PMN Number: K142237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48811226
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention