MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 70 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482317570

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Difficult to Remove (1528)

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

Event Date 10/28/2016

Event Type  malfunction  

Event Description

It was reported that the left screw from lilac bone was being attempted to be removed.Holding the screw head during locked the outer tube of screw driver, attempted to lose the screw, however removed screw head only.Removed the remaining screw part in lilac bone using adjustment driver and complete to remove screw whole.Additional information received from sr by phone on 4-nov-2016.Implanted xia3(ilia) and es2(lumbar) both for fractures on (b)(6) 2015.And removed xia3 as planned on (b)(6) 2016.

Manufacturer Narrative

Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was confirmed that the patient fused.Conclusion: the plausible root cause of the xia screw tulip head disengagement is due to patient's fusion and excessive force required to remove the screw.

Event Description

It was reported that the left screw from lilac bone was being attempted to be removed.Holding the screw head during locked the outer tube of screw driver, attempted to lose the screw, however removed screw head only.Removed the remaining screw part in lilac bone using adjustment driver and complete to remove screw whole.Additional information received from (b)(4) by phone on (b)(6) 2016.Implanted xia3(ilia) and es2(lumbar) both for fractures on (b)(4) 2015.And removed xia3 as planned on (b)(6) 2016.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 70 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: 6122748
• MDR Text Key: 61026680
• Report Number: 3005525032-2016-00148
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540562395
• UDI-Public: (01)04546540562395
• Combination Product (y/n): N
• 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: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 482317570
• Device Lot Number: B48274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2014
• 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
• Patient Weight: 60