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

Catalog Number E5112-07540

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/15/2016

Event Type  Injury  

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 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.

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 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
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: sandra gilbert ; 600 hope parkway se; leesburg, VA 20175 ; 5719192000
• MDR Report Key: 6187352
• MDR Text Key: 62787504
• Report Number: 3004774118-2016-00117
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857270701
• UDI-Public: 10888857270701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Physician
• Device Catalogue Number: E5112-07540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5101-90161 LOT EVNY; E5112-06540 LOT UNKNOWN
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 88