MAUDE Adverse Event Report: K2M, INC. REDUCTION JACK; MESA RAIL CRICKET®; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	801-90147
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
After the surgeon completed the procedure, he noticed via x-ray that the mesa rail cricket reduction jack he had used during the surgery left fractured components behind inside the patient.He then immediately removed the fractured pieces.Additional surgical time of under two hours reported but the exact length of time was not specified.
Event or Problem Description
After the surgeon completed the procedure, he noticed via x-ray that the mesa rail cricket reduction jack he had used during the surgery left fractured components behind inside the patient.He then immediately removed the fractured pieces.Additional surgical time of under two hours reported but the exact length of time was not specified.
Additional Manufacturer Narrative
Correction to d.3.And g.1.: updated from 'stryker spine- leesburg' to 'k2m, inc.' visual inspection: it was observed that one of the collet that holds the feet was fractured.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.Per ifu: translation of the concave thoracic apex to the mesa rail is performed by gradually tightening the rail crickets from the ends sequentially with progression towards the apex of the deformity.By performing the translation simultaneously from the outside-in with the rail crickets, the forces are spread across the entire construct.Once all rail crickets are maximally tightened, the mesa rail will be captured in each of the screw heads.One of the potential root causes could be the extensive lateral loading on the cricket feet when implanted in the patient.Another potential cause of the reported failure could be the cricket being stressed beyond its structural capacity.

• Brand Name: REDUCTION JACK; MESA RAIL CRICKET®
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9211432
• Report Number: 3004774118-2019-00129
• Device Sequence Number: 16571842
• Product Code: LXH
• UDI-Device Identifier: 10888857143708
• UDI-Public: 10888857143708
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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: Health Professional
• Device Catalogue Number: 801-90147
• Device Lot Number: GEKM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1