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

Catalog Number	101-10001
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/16/2016
Type of Reportable Event	Serious Injury
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.While the set screws exhibited abrasions indicative of rod contact, it was difficult to determine if the contact was optimal, as none of the set screws exhibited the ideal "windshield wiper" type abrasions.These type of abrasions indicate an optimally seated and reduced rod, and therefore, ideal contact between the rod and set screw.The patient was also diagnosed with neuromuscular scoliosis, which is a very difficult and complex deformity to correct.Since this type of deformity tends to place more stress on the construct, it likely contributed to the set screws backing out.However, no root cause(s) could be determined.The patient was revised successfully and is reportedly doing well.
Event or Problem Description
It was reported to k2m, inc.On (b)(6) 2016 that there was a revision surgery approximately 3 months post-op for a set screw back out.

• 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: 5510180
• Report Number: 3004774118-2016-00017
• Device Sequence Number: 16273389
• Product Code: KWP
• UDI-Device Identifier: 10888857003842
• UDI-Public: 10888857003842
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K042635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2016

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: 101-10001
• Device Lot Number: DTVY, DTVX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2016
• Initial Report FDA Received Date: 03/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: M101-07540 LOTS PMT, UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR