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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M, INC. POLYAXIAL SCREW; SIZE 6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 101-06545
Device Problem Fracture (1260)
Patient Problems Pain (1994); Injury (2348)
Event Date 06/26/2020
Event Type  Injury  
Event Description
The patient was revised for a denali screw, that fractured at the head of the tulip at the l5/s1 level, and a disc compression.The patient noted pain from the disc compression, not from the screw fracture.The patient fused and was reported to be doing "heavy manual labor." a new screw was placed in parallel at left side of s1.
 
Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the screw was fractured below the second thread.The distal part of the screw remains in the patient and was therefore not available for evaluation.Device and complaint history were reviewed and no relevant manufacturing issues or similar complaints were identified.As the screw was implanted 8 years ago, the most likely cause of the broken screw was determined to be material fatigue.Per the surgical technique, 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 (patient performs heavy manual labor).
 
Event Description
The patient was revised for a denali screw, that fractured at the head of the tulip at the l5/s1 level, and a disc compression.The patient noted pain from the disc compression, not from the screw fracture.The patient fused and was reported to be doing "heavy manual labor." a new screw was placed in parallel at left side of s1.
 
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Brand Name
POLYAXIAL SCREW; SIZE 6.5X45 MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key10307940
MDR Text Key199862323
Report Number3004774118-2020-00148
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857002777
UDI-Public10888857002777
Combination Product (y/n)N
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101-06545
Device Catalogue Number101-06545
Device Lot NumberAVRE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Date Manufacturer Received10/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
Patient Weight118
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