MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 801-36540M

Device Problem Migration (4003)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  Injury  

Event Description

It was reported that two mesa deformity uniplanar screws migrated 10 months post-operatively.Revision surgery has occurred and the screws have been replaced.This report will capture the first of two screws.

Manufacturer Narrative

New information about patient experiencing discomfort.

Event Description

After a patient began experiencing discomfort, an x-ray revealed two mesa deformity uniplanar screws migrated 10 months post-operatively.Revision surgery has occurred and the screws have been replaced.This report will capture the first of two screws.

Event Description

After a patient began experiencing discomfort, an x-ray revealed two mesa deformity uniplanar screws at l4 migrated 10 months post-operatively.Fusion was not achieved.Revision surgery has occurred and the screws have been replaced.This report will capture the first of two screws.

Manufacturer Narrative

Visual inspection: the screw was positioned in the locked state upon receipt.Loss of anodization can also be observed.Functional inspection: the screw was able to be unlocked and locked as intended.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The mesa deformity surgical technique was reviewed and the following relevant information was identified: potential adverse events associated with spinal fusion procedures include, but are not limited to pseudarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.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.It is possible that non-union contributed to the failure.According to the complainant, fusion was not achieved.Per the mesa surgical technique, these 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.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices in the absence of complete bone healing.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X40 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10891407
• MDR Text Key: 217938503
• Report Number: 3004774118-2020-00324
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857140264
• UDI-Public: 10888857140264
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801-36540M
• Device Catalogue Number: 801-36540M
• Device Lot Number: JEMR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 68