MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482316545

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/13/2016

Event Type  Injury  

Event Description

It was reported that; broken screws discovered upon revision surgery.Two screws were discovered to be fractured through the mid-shaft of the screw.Issue was noticed during imaging and confirmed when the screws were removed.Screws were replaced in the revision surgery.The broken screws were not the primary reason for the revision.The primary reason for the revision surgery was adjacent level disease at l2-3.Update 16-may-2016: ct images of broken screws available.

Manufacturer Narrative

Method: complaint history review; risk assessment.Results: no lot # was provided, so a manufacturing record review could not be performed.The device has not been returned for inspection, the activity level of the patient is unknown.It is unknown if the patient experienced any fall and the date of initial surgery is not known.Conclusion: the root cause of the event could not be determined with the given information.

Event Description

It was reported that; broken screws discovered upon revision surgery.Two screws were discovered to be fractured through the mid-shaft of the screw.Issue was noticed during imaging and confirmed when the screws were removed.Screws were replaced in the revision surgery.The broken screws were not the primary reason for the revision.The primary reason for the revision surgery was adjacent level disease at l2-3.Update - (b)(6) 2016: ct images of broken screws available.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 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: 5707555
• MDR Text Key: 46856444
• Report Number: 3005525032-2016-00063
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 04546540562241
• UDI-Public: (01)04546540562241
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

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: No Information
• Device Catalogue Number: 482316545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other