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

Catalog Number	M101-06550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not yet returned to manufacturer for evaluation, and a thorough investigation could not be completed as no lot number has been identified/confirmed in this case.Since the screw has not been returned no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.If more information becomes available manufacturer will file a follow-up report at that time.
Event or Problem Description
It was reported to k2m, inc on (b)(6) 2016 that a polyaxial screw fractured.Patient was revised.Dates unknown.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, storage and distribution records according to the description of the product used was conducted.All records revealed that the product lot was manufactured within specifications and distributed in accordance with all operating procedures.A review of the manufacturing and inspection records did not reveal any contributing information/trends.A fracture mechanism analysis determined that the screws likely fractured due to uniaxial bending fatigue (a low stress, high cycle failure).The metallurgical failure analysis also concluded that the screws were within specification.

• Brand Name: DENALI SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 751 miller dr se; suite f1; leesburg VA 20175
• MDR Report Key: 5474502
• Report Number: 3004774118-2016-00012
• Device Sequence Number: 517460
• Product Code: NKB
• UDI-Device Identifier: 10888857140264
• UDI-Public: 10888857140264
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2016

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
• Operator of Device: Physician
• Device Catalogue Number: M101-06550
• Device Lot Number: BWFR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2016
• Supplement Report FDA Received Date: 08/23/2016
• 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