MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPN

Device Problem Fracture (1260)

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

Event Date 01/06/2016

Event Type  Injury  

Event Description

It was reported that the patient underwent spinal surgery involving a screw which fractured post-operatively.

Manufacturer Narrative

Result: the reported device was not able to be identified since no product details were provided.A manufacturing record review, complaint history review or an nc/capa history could not be performed.Risk analysis could not be performed.Conclusion: the root cause of the reported event could not be determined due to lack of information and no product return for evaluation.Plausible causes include but not limited to: excessive patient post-op activities beyond surgeon recommendation.Patient experiences a fall.Patient non-fusion.Poor fixation construct.Device used beyond intended use.Improper screw insertion.Poor bone quality.Device not returned.

Event Description

It was reported that the patient underwent spinal surgery involving a screw which fractured post-operatively.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: marta koutsogiannis ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 8166839
• MDR Text Key: 130459271
• Report Number: 3004024955-2018-00058
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 01/31/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other