MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPE

Device Problems Insufficient Information (3190); Migration (4003)

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

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

A surgeon reported an unknown event involving an ozark view cervical plate and variable screws which occurred post-operatively.The devices are still implanted in the patient.This event will be reported conservatively as no additional information is available at this time.This report represents the second of the two screws.

Manufacturer Narrative

B1, b2, and h1 have been updated to reflect a serious injury as new information received indicated that the device was removed and replaced.Patient information has been received and recorded in section "a".H6(health impact grid): code has been updated to reflect revision surgery.H6(device grid): code has been updated to reflect device migration.Status and location of the device is currently unknown.

Event Description

A surgeon reported that two ozark variable screws at c6 migrated out of an ozark plate post-operatively.The patient was revised and the devices explanted.This report represents the second of the two ozark screws.

Manufacturer Narrative

The patient was implanted with a c3-c6 acdf on (b)(6) 2020.From the provided radiographic image, bilateral screw migration was confirmed at c6.Photos were provided of the explanted screws and locking cover of the plate.From the provided images, deformation can be seen on the explanted locking cover.The explanted devices were not returned for evaluation.Manufacturing records and complaint history were unable to be reviewed as the device catalog and lot number were not properly identified.Communication with field representative suggests that the locking cover was removed upon revision surgery and did not fracture post-operatively.From the observed deformation, it is possible that the cover was not completely locked as intended during the initial procedure.If the locking mechanism is not locked as intended, it can create instability within the construct, which can contribute to screw migration upon dynamic motion.As the explanted devices were not returned for investigation, the cause of the event could not be determined conclusively.

Event Description

A surgeon reported that two ozark variable screws at c6 migrated out of an ozark plate post-operatively.The patient was revised and the devices explanted.This report represents the second of the two ozark screws.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11108945
• MDR Text Key: 226094671
• Report Number: 3004774118-2020-00359
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K172104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2021

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 Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/22/2021; 03/29/2021
• Supplement Dates FDA Received: 02/19/2021; 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR