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.As per email communication, tap was used and tip of it broken intra-op.Majority of the broken fragments were retrieved.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.Device not returned.

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.As per email communication, tap was used and tip of it broken intra-op.Majority of the broken fragments were retrieved.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: 8149016
• MDR Text Key: 129875368
• Report Number: 0009617544-2018-00295
• 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: UNKNOWN
• 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