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

Catalog Number	801-36530M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.Since the screw remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.It was reported that multiple instruments could not engage and fully lock the screw.It is likely that the lips of outer collet became compromised at some point during the case.Once comprised, it becomes difficult for instruments to fully engage onto the screw head.However, without the actual implant and instruments used in the case no definitive root cause can be determined.While the implant was not returned, a general review of the manufacturing and inspection records revealed no additional information.
Event or Problem Description
On 11/30/2016, it was reported to k2m, inc.That a surgery took place in which a mesa screw was left implanted in a partially locked state.Surgery took place (b)(6) 2016.

• 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: 6212345
• Report Number: 3004774118-2016-00111
• Device Sequence Number: 19187101
• Product Code: NKB
• UDI-Device Identifier: 10888857140189
• UDI-Public: 10888857140189
• 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): 11/30/2016

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: 801-36530M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1