MAUDE Adverse Event Report: K2M, INC. UNKNOWN MESA SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number UNK_SPE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

Remains implanted.

Event Description

It was reported via clinical study that a patient experienced a dural tear during the procedure.The tear was repaired during the index surgery and the patient's hospital stay was extended.

Manufacturer Narrative

B2 has been corrected from "other serious (important medical events)" to "hospitalization-initial or prolonged".No devices were available for inspection nor was the device properly identified.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.It was reported that a patient experienced an unintended dural tear due to the procedure.The tear was repaired during the index surgery.The patient's hospital stay was extended 5 days due to the event; patient maintained flat in bed and log rolled for several days.Due to insufficient information, the root cause was unable to be determined conclusively.No further investigation for this event is possible at this time as no device and insufficient information was received by stryker.If devices and / or additional information become available, this investigation will be reopened.

Event Description

It was reported via clinical study that a patient experienced a dural tear during the procedure.The tear was repaired during the index surgery and the patient's hospital stay was extended.

• Brand Name: UNKNOWN MESA SCREW
• Type of Device: POSTERIOR CERVICAL 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: 12510108
• MDR Text Key: 272695655
• Report Number: 3004774118-2021-00284
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• 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; Hospitalization
• Patient Sex: Male