MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM BLOCKER; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48230000

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

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

Event Date 02/05/2015

Event Type  malfunction  

Event Description

It was reported; dr.Was doing a revision surgery.The constructed was from t10 to the pelvis.After exposing the hardware the s1 screw was broken and the rod on the right was broken.The blocker had also come out of the pelvic screws.The surgeons plan was to revise the hardware with two more pelvic screws and sister rod to the original construct.He placed the fist closed head screw on the left pelvis and then proceeded to put the second screw in right pelvis when the screw driver broke in two places.The screw was 3/4 down in the pelvis and could not be advanced or backed out.After many attempts to get the piece out the screw the surgeon put a 35 mm rod and a set screw in the closed head screw to see if he could remove it this was unsuccessful.He then proceeded to take a metal cutting burr and cut the head off the screw.He cut it then he removed it with a vise grip.He then put in a 9.5 x 90 open screw.He then proceeded to a put in the sister rods with rod to rod connectors.While bending the vitallium rod it broke while using the french bender.He cut another piece and it was place.All the rods and blockers were placed and final tightening began.While trying to final tighten the 9.5 x 90 pelvic screw the blocker would not hold it kept popping (3 attempts) the screw was removed and a 9.5 x 80 was placed and final tightening was completed.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the returned blocker was inspected and found to exhibit indentations that would be expected of an adequate tightening force.No visual issues were identified.It is possible that the length of implantation along with the patient's activity post-operatively contributed to the blocker migration.Conclusion: the root cause of the customer reported blocker disengagement could not be determined.

Event Description

It was reported; dr.Was doing a revision surgery.The constructed was from t10 to the pelvis.After exposing the hardware the s1 screw was broken and the rod on the right was broken.The blocker had also come out of the pelvic screws.The surgeons plan was to revise the hardware with two more pelvic screws and sister rod to the original construct.He placed the fist closed head screw on the left pelvis and then proceeded to put the second screw in right pelvis when the screw driver broke in two places.The screw was 3/4 down in the pelvis and could not be advanced or backed out.After many attempts to get the piece out the screw the surgeon put a 35 mm rod and a set screw in the closed head screw to see if he could remove it this was unsuccessful.He then proceeded to take a metal cutting burr and cut the head off the screw.He cut it then he removed it with a vise grip.He then put in a 9.5 x 90 open screw.He then proceeded to a put in the sister rods with rod to rod connectors.While bending the vitallium rod it broke while using the french bender.He cut another piece and it was place.All the rods and blockers were placed and final tightening began.While trying to final tighten the 9.5 x 90 pelvic screw the blocker would not hold it kept popping (3 attempts) the screw was removed and a 9.5 x 80 was placed and final tightening was completed.

• Brand Name: XIA 3 TITANIUM BLOCKER
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• 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: 4555292
• MDR Text Key: 5527838
• Report Number: 3005525032-2015-00022
• Device Sequence Number: 1
• Product Code: KWP
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 48230000
• Device Lot Number: FWL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2014
• 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