MAUDE Adverse Event Report: STRYKER STRYKER KYPHOPLASTY EQUIPMENT; DISPENSER, CEMENT

Lot Number 0001174064

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Fall (1848)

Event Date 06/20/2018

Event Type  Injury  

Event Description

Pt admitted on (b)(6) for frequent falls.Pt was noted to have an l1 compression tx.Pt presented to operating room on (b)(6) for l-1 kyphoplasty with trial of device product.Rep was present for procedure.Cement mixed and injected into pt as directed by rep.Rep informed staff that it would take 18 mins for cement to harden.Tried positioning the curved needle and removing the cannula after 7-8 mins, but cannula could not be removed.Attempt was made to pull the curved needle out, but it remained stuck in the pt.Neurosurgery contacted to assist.The decision was then made to take pt to the operating room for removal of needle.Needle removed in operating room without incident.Per provider conversation, this was a device failure by company.Frequency: once, route: unk.Dates of use: (b)(6) 2018.Reason for use: l1 compression fracture.

• Brand Name: STRYKER KYPHOPLASTY EQUIPMENT
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): STRYKER
• MDR Report Key: 7663502
• MDR Text Key: 113316130
• Report Number: MW5078244
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/02/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0001174064
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization