MAUDE Adverse Event Report: STRYKER SPINE-US ES2 CANNULATED MODULAR TAP; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 48280145

Device Problems Break (1069); Fracture (1260)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 11/20/2018

Event Type  Injury  

Event Description

It was reported that jamshidi broke intra-op and 40mm of it stuck in the patient pedicle.The pedicle hole was enlarged to remove stuck jamshidi.Majority of the broken fragments were retrieved.As per email communication, tap was used and bone stuck.A surgical delay of 2 hours was reported.

Manufacturer Narrative

Method: nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via email correspondence.Device was not returned and lot # was not provided, therefore device evaluation and product history review could not be performed.Conclusion: without device evaluation and product information, root cause could not be determined.

Event Description

It was reported that jamshidi broke intra-op and 40mm of it stuck in the patient pedicle.The pedicle hole was enlarged to remove stuck jamshidi.Majority of the broken fragments were retrieved.As per email communication, tap was used and bone stuck.A surgical delay of 2 hours was reported.

• Brand Name: ES2 CANNULATED MODULAR TAP
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8148881
• MDR Text Key: 129876247
• Report Number: 0009617544-2018-00294
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540710413
• UDI-Public: 04546540710413
• Combination Product (y/n): N
• PMA/PMN Number: K140400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48280145
• Device Lot Number: UNKNONW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other