MAUDE Adverse Event Report: K2M, INC. ROD CONNECTOR, CLOSED/OPEN; SIZE 5.5-6.0 / 5.5-6.0 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 2901-86055F

Device Problems Loose or Intermittent Connection (1371); Migration (4003)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2019

Event Type  Injury  

Event Description

A physician reported that during a revision surgery to replace a disengaged denali contour rod, three everest rods were found to be loose.This report captures the 1st of 3 everest rod connectors.The disengaged rod connector has been captured in a separate report.

Event Description

A physician reported that during a revision surgery to replace a disengaged denali contour rod, three everest rods were found to be loose.This report captures the 1st of 3 everest rod connectors.The disengaged rod connector has been captured in a separate report.

Manufacturer Narrative

Correction: updated from 'product problem' to 'adverse event and product problem' correction: updated from 'stryker spine- leesburg' to 'k2m, inc.' correction: updated from 'malfunction' to 'serious injury' visual inspection revealed that the inferior surfaces of each set screw exhibited wear patterns consistent with post-operative movement within the construct.One of the set screws presented significant radial wear on the inferior surface, which may indicate that the rod was not fully reduced during final tightening.The main body of the connector exhibited signs of use, but no visual non-conformance was identified.Device and complaint history records were reviewed for the provided lot number and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: the rod-to-rod connectors are another option for joining two parallel rods.The rod-to-rod connectors come in closed/closed and open/closed styles.The open/closed style connector requires a set screw.The implants are final tightened using either the torque limiting wrench or the torque indicating wrench.Visual inspection of the returned set screws, suggests that the root cause of this failure mode was that the subject rod was not fully reduced in the connector.Incomplete reduction may have resulted in insufficient capture force being delivered by the set screw during final tightening.An insufficient capture may result in unanticipated motion within the construct post-operatively, which may result in loosening and disengagement of the associated hardware.

• Brand Name: ROD CONNECTOR, CLOSED/OPEN; SIZE 5.5-6.0 / 5.5-6.0 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8875406
• MDR Text Key: 153873270
• Report Number: 3004774118-2019-00078
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K143334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2901-86055F
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR