MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482316540

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problems Discomfort (2330); Device Embedded In Tissue or Plaque (3165)

Event Date 02/13/2015

Event Type  Injury  

Event Description

Screw broke in half in patient's sacrum.Patient experienced discomfort from loose hardware, requiring revision surgery to remove broken screw.Screw tulip was removed, but fractured shaft was left in patient.

Manufacturer Narrative

Method: device not returned; results: because no device was received back for evaluation, testing and inspection could not be performed to aid in root cause analysis.However, it was confirmed that the level that fractured had not fused.It is stated in the ifu that these devices are only mean to provide support during fusion and are not meant to indefinitely withstand the loads of normal bone.Conclusion: it is likely that the fatigue fractured due to the stress of bearing the load of a spine that had not fused.

Event Description

Screw broke in half in patient's sacrum.Patient experienced discomfort from loose hardware, requiring revision surgery to remove broken screw.Screw tulip was removed, but fractured shaft was left in patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4578043
• MDR Text Key: 19804691
• Report Number: 3005525032-2015-00029
• 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: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482316540
• Device Lot Number: B04930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2010
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR