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

Catalog Number	801-06545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/28/2017
Type of Reportable Event	Malfunction
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.It was reported that the patient fused at l4-l5.Fusion at l5-s1 could not be confirmed by the radiologist; therefore, a potential pseudarthrosis may have contributed to this incident.As stated in our pedicle screw ifu, our screws are intended to provide temporary posterior fixation as an adjunct to fusion.In the event of a non-union, the screws may have been overloaded or failed in fatigue.The patient also has a history of smoking, which is listed as a contraindication in our ifu due to its negative effect on bony union.In situ.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with screw fractures.The patient reportedly had screw fractures approximately 12 months post-op.The patient has not been revised at this time.

• Brand Name: MESA SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6595523
• Report Number: 3004774118-2017-00056
• Device Sequence Number: 739180
• Product Code: NKB
• UDI-Device Identifier: 10888857136168
• UDI-Public: 10888857136168
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 801-06545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2017
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 79