MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY THREE LEVEL PLATE SIZE 57; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 48811357

Device Problems Device Slipped (1584); Deformation Due to Compressive Stress (2889); Material Protrusion/Extrusion (2979)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

Device is still in patient.

Event Description

Plate was identified with 2 lowest screws backed out.Patient was brought to surgery to remove the two protruding screws.The 2 screws were removed and the plate remains implanted.

Event Description

Plate was identified with 2 lowest screws backed out.Patient was brought to surgery to remove the two protruding screws.The 2 screws were removed and the plate remains implanted.

Manufacturer Narrative

Method: labelling review, risk assessment.Result: the customer reported event was confirmed via correspondence.The device was not returned, therefore product inspection could not be performed.No lot # was provided, so a manufacturing record review could not be performed.Per the report from the rep, patient had a motor vehicle collision.It's unknown when the patient had motor vehicle collision.Conclusion: the root cause of the reported event is likely to be the motor vehicle collision.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 57
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7903561
• MDR Text Key: 121558430
• Report Number: 0009617544-2018-00231
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152323
• UDI-Public: 07613252152323
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48811357
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 91