MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 801-36545M

Device Problem Fracture (1260)

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

Event Date 07/08/2021

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that during a control x-ray, a mesa deformity uniplanar screw revealed shaft breakage.The event will require revision surgery.

Event Description

It was reported that during a control x-ray, a mesa deformity uniplanar screw revealed shaft breakage.Revision surgery has occurred.

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, and no relevant manufacturing issues or similar complaints were identified.It was reported that the patient did not experience any external trauma.Post op activity is unknown, fusion is unknown, and it is unknown if any issues occurred during locking/if rod was fully reduced.It was reported that rod overhang was adequate.No operative notes or x-rays were provided.The screw was not returned for evaluation.Without x-rays of the construct or the device itself, a cause cannot be determined.If further information becomes available, this investigation will be reopened and updated accordingly.H3 other text: return status of the device is unknown.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 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: 12356118
• MDR Text Key: 267750988
• Report Number: 3004774118-2021-00259
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857140301
• UDI-Public: 10888857140301
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801-36545M
• Device Catalogue Number: 801-36545M
• Device Lot Number: MJCU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention