MAUDE Adverse Event Report: K2M, INC. EVEREST PEDICLE SCREW SYSTEM; SET SCREW

Catalog Number B111-55500

Device Problem Insufficient Information (3190)

Patient Problem Non-union Bone Fracture (2369)

Event Date 02/29/2012

Event Type  Injury  

Event Description

Bilateral cocr rod fracture at the level of the s1 screws in an l3-s1 everest construct approximately 3 months post-operatively.Patient reportedly had a pseudoarthrosis and required revision.

Manufacturer Narrative

Based on a review of the records provided, the patient had developed a pseudoarthrosis.The everest cocr rods were reportedly removed and replaced with two titanium rods however, the screws remained intact.Set screws, cross-connectors, rods and transverse connectors were removed from l3 to the ilium and lateral transverse connectors were placed to secure the posterior construct to the ilium bilaterally.A general review of the manufacturing and inspection records for the rods were performed however, without the specific lot of parts or the actual parts to evaluate, no firm conclusions can be drawn as to the root cause of the incident.Pseudoarthrosis could however, be a contributory factor.Parts not returned.

• Brand Name: EVEREST PEDICLE SCREW SYSTEM
• Type of Device: SET SCREW
• Manufacturer (Section D): K2M, INC.; 751 miller drive se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 751 miller drive se; leesburg VA 20175
• Manufacturer Contact: rich woods ; 751 miller drive se; leesburg, VA 20175 ; 7037773155
• MDR Report Key: 3709512
• MDR Text Key: 16596471
• Report Number: 3004774118-2014-00013
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K103440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/27/2014

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?: No
• Device Operator: Physician
• Device Catalogue Number: B111-55500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2014
• Initial Date FDA Received: 03/28/2014
• 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