MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND (MDR) XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 48232601

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

It was reported that surgeon was bending a rod with a french bender.The bending arc was set at 4.As he proceeded to bend the rod, it broke apart.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the returned rod was confirmed to have fractured at the laser marking dot.No relevant manufacturing issues were identified.Conclusion: the ultimate cause of the fracture is unknown, but likely dependent on site specific loading as well as the severity of the bending angle and the orientation of the laser marking relative to the bending direction.

Event Description

It was reported that surgeon was bending a rod with a french bender.The bending arc was set at 4.As he proceeded to bend the rod, it broke apart.

• Brand Name: XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; -; la chaux-de-fonds 02300 ; CH 02300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; -; la chaux-de-fonds 02300 ; CH 02300
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4836402
• MDR Text Key: 5937493
• Report Number: 3005525032-2015-00069
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48232601
• Device Lot Number: HC9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2014
• 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