MAUDE Adverse Event Report: K2M, INC. MESA SMALL STATURE SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	3011-H45500
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.In situ.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible rod slip.The patient reportedly had a possible rod slip approximately 7 months post-op.Patient has not been revised at this time.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.Review of parts and events suggest the right side 4.5mm rod slipped cephalad from the construct iliac screw.The cephalad end of the rod could not be confirmed as a fatigue or instantaneous fracture due to the rubbing wear to the rod end face.Fluoro sequences indicate rod disengagement occurred prior to rod fracture.This sequence and absence of supporting screws at the cephalad adjacent level suggest the event rod experienced excessive loading at the l3-l4 level.Small rod size (4.5mm) related to patient size and weight could contribute to premature rod slip.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible rod slip and fracture.The patient reportedly had a possible rod slip and fracture approximately 7 months post-op.Patient was revised (b)(6) 2017.

• Brand Name: MESA SMALL STATURE SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6657465
• Report Number: 3004774118-2017-00067
• Device Sequence Number: 1286048
• Product Code: KWP
• UDI-Device Identifier: 10888857047204
• UDI-Public: 10888857047204
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2017

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
• Operator of Device: Physician
• Device Catalogue Number: 3011-H45500
• Device Lot Number: BLTX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR