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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 5.5 X 40MM; PEDICLE SCREW SPINAL SYSTEM

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STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 5.5 X 40MM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 03821540
Device Problems Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384); Material Separation (1562)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2015
Event Type  malfunction  
Event Description
It was reported that; surgeon was performing a scoliosis surgery.Surgeon was derotating with tubes and screws and the screw head broke and separated from the body.Surgeon proceeded to remove that screw and changed by another one.Again, during derotation, the screw was broken.He removed the screw, placed a new one and again, during the rotation, the screw broke.At a total, 3 screws were broken on the attempts.No impact to the patient was caused.Surgery was delayed in 20 minutes, due to the replacement of screws.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: protrusion of the bone screw through the base of the tulip was observed and suggests that excess torque was applied during the derotation maneuver.Review of the correspondence confirms that the event occurred during a derotation maneuver involving multiple suk tubes attached to the screws, clamped together.Conclusion: various surgical factors may have contributed to the event, involving the positioning of the tubes and the surgeon's technique.However, these factors could not be replicated during device evaluation, and as a result the root cause of the reported event could not be determined conclusively.
 
Event Description
It was reported that; surgeon was performing a scoliosis surgery.Surgeon was derotating with tubes and screws and the screw head broke and separated from the body.Surgeon proceeded to remove that screw and changed by another one.Again, during derotation, the screw was broken.He removed the screw, placed a new one and again, during the rotation, the screw broke.At a total, 3 screws were broken on the attempts.No impact to the patient was caused.Surgery was delayed in 20 minutes, due to the replacement of screws.
 
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Brand Name
XIA LP POLYAXIAL SCREW 5.5 X 40MM
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 Key5009071
MDR Text Key24435108
Report Number3005525032-2015-00097
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K060361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Followup
Report Date 07/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number03821540
Device Lot NumberB47271
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/17/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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