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

Catalog Number	E5112-07540
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.Insitu.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a surgery took place in which the surgery time was extended by 25% due to screw not functioning as intended.Surgery took place on (b)(6) 2016.
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 to k2m, inc.That the screws' tabs splayed open several times during screw insertion, due to over-threading the inserters, and that the tabs on one of the screws broke prematurely during final tightening of the set screw.While the tabs can break under outward, splaying forces and torsional loads, manufacturer could not replicate this incident by over -tightening the inserter, or by tightening the set screw.Therefore no root cause could be determined.While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.
Event or Problem Description
On 11.16.2016 it was reported to k2m, inc.That a surgery took place in which the surgery time was extended by 25% due to screw not functioning as intended.Surgery took place on (b)(6) 2016.

• Brand Name: EVEREST SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6187352
• Report Number: 3004774118-2016-00117
• Device Sequence Number: 1003444
• Product Code: NKB
• UDI-Device Identifier: 10888857270701
• UDI-Public: 10888857270701
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151727
• 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,Followup
• Report Date (Section B): 11/16/2016

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: E5112-07540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/11/2017
• 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: 5101-90161 LOT EVNY; E5112-06540 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Weight: 88