MAUDE Adverse Event Report: K2M, INC. UNIPLANAR SCREW; SIZE Ø5.5X30 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-35530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that approximately 1 month post-operatively, the patient was experiencing significant pain.Subsequently, it was discovered 4 mesa uniplanar screws had loosened.Revision surgery has not been performed at this time.This report captures the fourth screw.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, and no adverse trends were observed.The patient reported event of migration and loosening of mesa devices which were implanted in october 2021 was confirmed via correspondence with the representative.A revision surgery is planned but has not occurred yet.It was further reported that the entire k2m tray of the mesa system was used for screw preparation.The hole was made using a 3.5mm pediguard to verify adequate passage within the pedicle.Fluoroscopy and intraoperative monitoring were used to verify the position of the screws.It was also reported that the patient has a known diagnosis of osteoporosis and that the fractures (despite trauma on the beach) were largely due to osteoporosis.The representative reported that before and after surgery, it was explained to the patient that one of the risks was the loosening of instruments due to osteoporosis.The mesa device ifu and surgical technique were reviewed: "potential adverse events include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting.¿ ¿patient selection and compliance is extremely important.Based on fatigue testing results, the k2m range spinal system has been determined to be substantially equivalent to predicate devices however, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact the performance of this system.Spinal implant surgery on patients with conditions listed under contraindications may not be candidates for this procedure.The patient must be made aware of the limitations of the implant and that physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices." as the ifu warns against insufficient bone stock as it can be a possible cause for implant fractures and loosening and based on the patient's diagnosis of osteoporosis, the most likely cause is insufficient bone stock causing the screws to migrate.
Event or Problem Description
It was reported that approximately 1 month post-operatively, the patient was experiencing significant pain.Subsequently, it was discovered 4 mesa uniplanar screws had loosened.Revision surgery has not been performed at this time.This report captures the fourth screw.

• Brand Name: UNIPLANAR SCREW; SIZE Ø5.5X30 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13971535
• Report Number: 3004774118-2022-00119
• Device Sequence Number: 19952421
• Product Code: NKB
• UDI-Device Identifier: 10888857139787
• UDI-Public: 10888857139787
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 801-35530
• Device Catalogue Number: 801-35530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female