MAUDE Adverse Event Report: K2M INC. MESA POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	801-05535
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient that was originally operated on in 2016, underwent revision surgery due to the patient presenting with pain.During surgery it was noted that the mesa polyaxial screw was broken.
Event or Problem Description
A patient that was originally operated on in 2016, underwent revision surgery due to the patient presenting with pain.During surgery it was noted that the mesa polyaxial screw was broken.
Event or Problem Description
A patient that was originally operated on in 2016, underwent revision surgery due to the patient presenting with pain.During surgery it was noted that the mesa polyaxial screw was broken.
Additional Manufacturer Narrative
It was reported that a mesa polyaxial screw broke postoperatively.The patient underwent surgery on (b)(6) 2016 at levels l4-l5-s1.Approximately two years postoperatively, the patient presented pain.During removal, it was observed that the mesa polyaxial screw had fractured.The screw and all fractured components were successfully removed.The explanted hardware was not available for evaluation; however, the failure was confirmed through photos.Upon review, it was observed that the screw shank had fractured at the fifth thread distal to the screw head assembly.It was reported that the patient had already fused.According to the product insert, internal fixation devices are load sharing devices which maintain alignment until healing occurs.Implants are intended to provide temporary stabilization and removed after complete healing.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.It is possible the failure occurred in fatigue.Screws at the most caudal level of the construct are subjected to more stress.Repeated bending motions can compound cantilever forces at the proximal screw shank, resulting in a failure of this nature.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Post market surveillance will continue to monitor this issue.Correction: implant: from (b)(6) 2016 to (b)(6) 2016.Explant: from (b)(6) 2019 to (b)(6) 2019.
Event or Problem Description
A patient that was originally operated on in 2016, underwent revision surgery due to the patient presenting with pain.During surgery it was noted that the mesa polyaxial screw was broken.

• Brand Name: MESA POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8787125
• Report Number: 3004774118-2019-01066
• Device Sequence Number: 16810971
• Product Code: NKB
• UDI-Device Identifier: 10888857135536
• UDI-Public: 10888857135536
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/01/2019

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: Health Professional
• Device Catalogue Number: 801-05535
• Device Lot Number: DJMW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 06/14/2019; 06/14/2019; 10/31/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/23/2019; 08/23/2019; 11/01/2019
• 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: Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 71