MAUDE Adverse Event Report: K2M, INC. MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 6201-06550-G1

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2022

Event Type  Injury  

Manufacturer Narrative

Hospital discarded.

Event Description

It was reported that during intra-operative final tightening, a mesa 2 deformity polyaxial screw pulled out of the left l4 pedicle.The rail was removed from all the screws on the left side, re-contoured and positioned, and a new screw was inserted.The procedure was completed successfully with a 2.5 surgical delay.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Complaint history records were reviewed for this catalog number, no adverse trends were identified.It was reported that during final locking of the mesa screws, a mesa screw pulled out of the left l4 pedicle.The procedure was completed by removing the rail from all the screws on the left side, the screw pathway was modified to ensure more medial placement to allow for a longer screw to be inserted.The pathway was filled with bone graft before placement of the longer screw.The rail was re-contoured and positioned & a cross-connector was added for additional stability.The screws were reported to not be damaged.The screw holes were prepared using an awl and probes and then tapped.It is unknown what size tap was used.The mesa rail quick locker was used for final locking.The rod was reported to be fully reduced using mesa 2 crickets in sequential fashion.The surgeon did not appear to apply excessive force during final locking.The patient's bone quality is unknown.As the screw was not returned, a definite cause cannot be determined.It is unknown what size tap was used, overtapping the screw hole, or preparing too large of a hole for the screw could result in decreased screw purchase which could cause the screw to pull out.It is also unknown what the patient's bone quality was, poor bone quality could also lead to decreased screw purchase.Damage to the screw, excessive force during locking, and/or excess stress on this screw due to construct design could also have contributed to the event.

Event Description

It was reported that during intra-operative final tightening, a mesa 2 deformity polyaxial screw pulled out of the left l4 pedicle.The rail was removed from all the screws on the left side, re-contoured and positioned, and a new screw was inserted.The procedure was completed successfully with a 2.5 surgical delay.

• Brand Name: MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X50 MM
• Type of Device: 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: 14336546
• MDR Text Key: 291623504
• Report Number: 3004774118-2022-00179
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857263369
• UDI-Public: 10888857263369
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K143334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

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
• Device Operator: Health Professional
• Device Model Number: 6201-06550-G1
• Device Catalogue Number: 6201-06550-G1
• Device Lot Number: KYNM-4495511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Sex: Male