T-PAL SPACER APPLICATOR KNOB 03812004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-25 for T-PAL SPACER APPLICATOR KNOB 03812004 manufactured by Depuy Synthes.

Event Text Entries

[3611292] On (b)(6) 2013, this pt was taken for elective surgical decompression and thoraco-lumbar fusion. During bone graft placement at l2-l3, there was immediate loss of somatosensory evoked potentials from bilateral lower extremities. Immediate intraoperative procedures were undertaken to address this complication. Upon exploration, the interbody fusion peek cage was noted to be within the spinal canal, resulting in compression of the spinal canal, causing bilateral lower extremity weakness. This smda is being submitted based on concerns regarding the inability to confirm appropriate tension on applicator knob, potentially allowing malposition of the cage and cage fracture.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3254641
• MDR Report Key: 3254641
• Date Received: 2013-07-25
• Date of Report: 2013-07-12
• Date of Event: 2013-07-02
• Date Facility Aware: 2013-07-02
• Report Date: 2013-07-12
• Date Reported to FDA: 2013-07-12
• Date Reported to Mfgr: 2013-07-12
• Date Added to Maude: 2013-07-31
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: T-PAL SPACER APPLICATOR KNOB
• Generic Name: SPACER APPLICATOR KNOB
• Product Code: LXH
• Date Received: 2013-07-25
• Model Number: 03812004
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY SYNTHES
• Manufacturer Address: WEST CHESTER PA 19380 US 19380

Device Sequence Number: 2

• Brand Name: 11MM X 10 X 28MM CAGE
• Generic Name: CAGE
• Product Code: MCV
• Date Received: 2013-07-25
• Model Number: 08812011
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEPUY SYNTHES
• Manufacturer Address: WEST CHESTER PA 19380 US 19380

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2013-07-25