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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 48233540
Device Problems Break (1069); Migration (4003)
Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348)
Event Date 04/11/2018
Event Type  Injury  
Event Description
It was reported that a patient had a procedure on (b)(6) 2016 for adolescent scoliosis correction.Surgery went well, correction obtained with no complication.Screws placed t3-l3.Patient was brought back for surgery (b)(6) 2018 due to l3 left sided screw backed out and potential cause of pain.Surgeon decided to remove all instrumentation as the spine has fused and instrumentation no longer needed.On removing the screws, one of the screws was found broken.This caused no issue to the patient and wasn't the reason for the revision surgery.The patient had a total of 21 screws in originally.One screw had backed out and one screw was broken.
 
Manufacturer Narrative
The event was confirmed based on the communication with the sales representative.X rays were provided for evaluation.The screw was lost at the hospital during sterilization and is unavailable for evaluation.Manufacturing history was reviewed and no issues were identified.The patient was revised approximately 2 years after the initial surgery due to left screw backing out potentially causing pain.The patient had good bone quality, no co-morbidities, nonsmoker, adolescent idiopathic scoliosis condition, normal post op activity level and did not suffer a fall.It was reported that the patient fused and the instrumentation was no longer needed.It is stated in the ifu that "these implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed." the device was implanted for a period of almost 2 years.The most likely root cause is device was used past its functional purpose, with excessive force placed by the surgeon and non tapping possibly contributing to the event.
 
Event Description
It was reported that a patient had a procedure on (b)(6) 2016 for adolescent scoliosis correction.Surgery went well, correction obtained with no complication.Screws placed t3-l3.Patient was brought back for surgery (b)(6) 2018 due to l3 left sided screw backed out and potential cause of pain.Surgeon decided to remove all instrumentation as the spine has fused and instrumentation no longer needed.On removing the screws, one of the screws was found broken.This caused no issue to the patient and wasn't the reason for the revision surgery.The patient had a total of 21 screws in originally.One screw had backed out and one screw was broken.
 
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Brand Name
XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key7483031
MDR Text Key107222616
Report Number0009617544-2018-00100
Device Sequence Number1
Product Code OSH
UDI-Device Identifier07613327001037
UDI-Public(01)07613327001037
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K113666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number48233540
Device Catalogue Number48233540
Device Lot Number14H339
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2014
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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