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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US 8.5X90 POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22

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STRYKER SPINE-US 8.5X90 POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22 Back to Search Results
Catalog Number 482618590
Device Problems Break (1069); Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 03/07/2018
Event Type  Injury  
Event Description
It was reported that at the 2 week post operative visit, an x-ray indicated that the tulip popped of the shank of the screw. The patient underwent revision surgery to remove the broken tulip and screw. Another size screw was implanted.
 
Manufacturer Narrative
The customer reported event was confirmed via visual inspection and x rays. The construct was returned with the screw, connector, and 2 blockers. The tulip head of the screw was disengaged from the shank. The connector was still attached to the tulip head with a blocker tightly holding the connector in place. There was deformation on the tulip head locking ring and the head of the screw shank. The provided x ray also shows the tulip head disengaged from the screw shank. Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified. Conclusion: it was reported that the patient may have fell in rehab facility. It is possible that the force of the fall caused the tulip head to disengage and cause the damage seen on the screw as the tulip head locking ring and the head of the screw shank were both deformed. The most likely root cause is patient fall.
 
Event Description
It was reported that at the 2 week post operative visit, an x-ray indicated that the tulip popped of the shank of the screw. The patient underwent revision surgery to remove the broken tulip and screw. Another size screw was implanted.
 
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Brand Name8.5X90 POLYAXIAL SCREW
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
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allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
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la chaux-de-fonds 2300
CH 2300
Manufacturer Contact
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key7390652
MDR Text Key104136146
Report Number3005525032-2018-00020
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number482618590
Device Lot NumberB73627
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/02/2018 Patient Sequence Number: 1
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