MAUDE Adverse Event Report: K2M, INC. DEFORMITY POLYAXIAL SCREW; SIZE 4.0X30 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	3001-04030
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Neck Pain (2433)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported via clinical study that a patient experienced back and neck pain approximately 1 year after their index surgery.This was initially reported in relation to a cascadia cage reported via mrn 3004774118-2020-00081.Additional information received on (b)(6) 2021 indicated there was no complaint against this cascadia cage and it was in fact two mesa screws that had migrated.It was noted that a rod had disconnected from a mesa screw at right l5.The patient was revised and it was discovered at this time that the screw at left l6 was also loose.The two pedicle screws, at right l5 and left l6, were then removed and replaced.This report captures the migrated screw at right l5.
Additional Manufacturer Narrative
The device was not able to be physically inspected, but x-rays were available for evaluation.Upon review, it was observed that the screws implanted at right l5 and left l6 were about to disengage from their associated rods.Device and history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for tis catalog, no similar complaints were identified.Stryker spine received additional information that the patient had fallen post-operatively following a muscle spasm.According to the adverse event report, the spasmodic nature of the subject's musculature caused pain in the lower back and left leg.Following an x-ray, it was discovered that the rod had disconnected from a mesa screw at right l5.The patient was then revised and it was discovered at this time that the screw at left l6 was also loose.The two pedicle screws, at right l5 and left l6 were then removed and replaced.As no devices were available for evaluation, the root cause could not be determined conclusively.Nonunion may have contributed to the failure.According to the ifu, these internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Additionally, patient trauma may have introduced unanticipated loading to the construct, leading to the axial slip along the rod.
Event or Problem Description
It was reported via clinical study that a patient experienced back and neck pain approximately 1 year after their index surgery.This was initially reported in relation to a cascadia cage reported via mrn 3004774118-2020-00081.Additional information received on 7/22/2021 indicated there was no complaint against this cascadia cage and it was in fact two mesa screws that had migrated.It was noted that a rod had disconnected from a mesa screw at right l5.The patient was revised and it was discovered at this time that the screw at left l6 was also loose.The two pedicle screws, at right l5 and left l6, were then removed and replaced.This report captures the migrated screw at right l5.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE 4.0X30 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12304860
• Report Number: 3004774118-2021-00248
• Device Sequence Number: 17027337
• Product Code: NKB
• UDI-Device Identifier: 10888857046184
• UDI-Public: 10888857046184
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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 Model Number: 3001-04030
• Device Catalogue Number: 3001-04030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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