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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. SET SCREW; ATR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M, INC. SET SCREW; ATR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 2901-10001
Device Problem Migration (4003)
Patient Problem Injury (2348)
Event Date 02/01/2020
Event Type  Injury  
Manufacturer Narrative
Status and location of the device is unknown.
 
Event Description
It was reported that a patient underwent revision surgery to address 4 everest atr set screws which migrated approximately 5 weeks after implantation.The physician reported that the patient was lifting heavy objects after the procedure and then, "felt their spine go loose." this reported represents the fourth of the four set screws.
 
Event Description
It was reported that a patient underwent revision surgery to address 4 everest atr set screws which migrated approximately 5 weeks after implantation.The physician reported that the patient was lifting heavy objects after the procedure and then, "felt their spine go loose." this report represents the fourth of the four set screws.
 
Manufacturer Narrative
Visual, functional, material, and dimensional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.The everest surgical technique was reviewed and the following relevant information was identified: it is the responsibility of the physician to adequately instruct the patient that postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.The root cause could not be determined conclusively.It could not be determined if the set screws were placed with sufficient torque or if the rods were fully reduced.This may have led to sub-optimal engagement between the set screw and the rod, which may have contributed to loosening and eventually disengagement.Patient compliance may have also played a factor, the patient was reportedly lifting heavy objects after the procedure.
 
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Brand Name
SET SCREW; ATR
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key9873890
MDR Text Key184746513
Report Number3004774118-2020-00055
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857037939
UDI-Public10888857037939
Combination Product (y/n)N
PMA/PMN Number
K133944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2901-10001
Device Catalogue Number2901-10001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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