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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPN
Device Problems Break (1069); Disconnection (1171); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2018
Event Type  malfunction  
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.
 
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
Method: x-rays, photos, risk assessment; result: the event was confirmed based on the communication with the sales representative and device images provided.X rays were provided for evaluation.The screw was lost at the hospital during sterilization and is unavailable for evaluation.Manufacturing history was not reviewed as lot # was not provided.The tulip disengagement was found during a revision surgery, however, the cause of the revision surgery was due to a screw pullout which was reported under separate product inquiry.The tulip disengagement did not cause any patient harm.Conclusion: the patient was revised approximately 2 years after the initial surgery due to left screw backing out potentially causing pain.The tulip disengagement was found during a revision surgery.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.
 
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Brand Name
UNKNOWN_SPINE_PRODUCT
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key7483032
MDR Text Key107463697
Report Number0009617544-2018-00101
Device Sequence Number1
Product Code OSH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
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? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_SPN
Was Device Available for Evaluation? No
Date Manufacturer Received06/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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