MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE 7.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	E5112-07545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not returned.
Event or Problem Description
A physician reported that an everest xt fenestrated polyaxial screw extended tab, implanted in l5, fractured intra-operatively.Revision surgery was performed as the extended tab was left in patient.
Additional Manufacturer Narrative
Correction to b.3.: updated from (b)(6) 2019'.
Event or Problem Description
A physician reported that an everest xt fenestrated polyaxial screw extended tab, implanted in l5, fractured intra-operatively.Revision surgery was performed as the extended tab was left in patient.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, x-rays were provided by the rep.Upon review, it was observed that the cobalt chrome tab component was free floating.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: tab removal slide the tab removal tool over the xt screw until the distal tip of the instrument is flush with the top of the screw head.Break the tab off by rocking the instrument back and forth until the entire tab is fully detached from the screw head.The everest minimally invasive xt tab removal guide was reviewed and the following relevant information was identified: step 4: after the cap has been removed, insert the tab removal tool (5101-90141) over the now open tabs.When correctly positioned, the tab removal tool should be fully seated on the everest mi xt screw, sitting flush at the screw tulip-tab connection.Step 5: once positioned over the tabs, the tab removal tool can be pushed medially or laterally to remove the extended tab from the everest mi xt screw.Step 6: remove the tab removal tool and tabs together.Option 2: step 1: insert the recovery alignment tool (5101-90128) through the top of the everest mi xt screw.The "rod slot" indicator on the instrument should be in-line with the rod slots of the everest mi xt screw.The recovery alignment tool, when positioned correctly, will sit flush with the top of the set screw.Step 2: with the recovery alignment tool positioned within the everest mi xt screw, grab the exterior of the extended tabs or recover alignment tool and push medially or laterally to break the extended tabs from the everest mi xt screw.Step 3: if one side of the extended tab is remaining, this can be broken by pushing away from the screw tulip by hand.Although the root cause cannot be determined definitively, it is likely the tabs were not removed properly.
Event or Problem Description
A physician reported that an everest xt fenestrated polyaxial screw extended tab, implanted in l5, fractured intra-operatively.Revision surgery was performed as the extended tab was left in patient.

• Brand Name: POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE 7.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9560163
• Report Number: 3004774118-2020-00002
• Device Sequence Number: 2245614
• Product Code: NKB
• UDI-Device Identifier: 10888857270718
• UDI-Public: 10888857270718
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K151727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2020

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: No Information
• Device Model Number: E5112-07545
• Device Catalogue Number: E5112-07545
• Device Lot Number: GPVW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/13/2020; 02/28/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/04/2020; 07/31/2020
• 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