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

Catalog Number	2911-06540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/08/2017
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.
Event or Problem Description
On (b)(6) 2017, it was reported to k2m, inc.That a patient presented with a possible screw break.The patient reportedly had possible screw break approximately 5 months post-op.There are no plans to revise at this time.
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.Previous similar incidents suggest that the screw was overloaded (a high stress, low cycle failure) or fractured in fatigue (a low stress, high cycle failure).
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a screw break.The patient reportedly had a screw break approximately 5 months post-op.There are no plans to revise at this time.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The patient was revised and the investigation has been re-opened.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a screw break.The patient reportedly had a screw break approximately 5 months post-op.The patient was revised on (b)(6) 2017.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.The fracture surfaces of the event screw were examined.The fracture face of the proximal half (head portion) had a polished appearance indicating contact rubbing against the fracture face edge of the opposing distal thread body.The distal portion fracture face area not exhibiting contact rubbing indicated sudden failure.Portions of the fracture face had markings consistent with damage from the burr tool utilized for extraction.The investigation indicates sudden overload failure of one l5 screw.No direct cause of the overload could be concluded.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a screw break.The patient reportedly had a screw break approximately 5 months post-op.The patient was revised on (b)(6) 2017.

• 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: 6460280
• Report Number: 3004774118-2017-00031
• Device Sequence Number: 563840
• Product Code: NKB
• UDI-Device Identifier: 10888857042339
• UDI-Public: 10888857042339
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/08/2017

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 2911-06540
• Device Lot Number: DUBW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 03/08/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/05/2017; 06/23/2017; 07/20/2017
• 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
• Patient Age: 52 YR
• Patient Weight: 66