MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 30 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482317530

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384)

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

Event Date 12/15/2015

Event Type  malfunction  

Event Description

It was reported that the screw tulip head came off during distraction.

Manufacturer Narrative

(b)(4).Visual inspection; functional inspection; device history review; complaint history review; risk assessment; a large dent was observed on the screw head, which confirms that the device had been final tightened.It was stated that the event occurred during distraction.Per the surgical technique, distraction should be performed when the blockers are not final tightened, as this can result in excess force being applied to the screw.The most likely cause of the reported event is distraction of the construct after the blocker had been final tightened.

Event Description

It was reported that the screw tulip head came off during distraction.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 30 MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5353299
• MDR Text Key: 35757442
• Report Number: 3005525032-2016-00001
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 482317530
• Device Lot Number: B54380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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