MAUDE Adverse Event Report: K2M, INC. DEFORMITY POLYAXIAL SCREW; SIZE 4.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	3001-04540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mesa small stature deformity polyaxial screw, implanted in l1, disengaged post-operatively.During revision surgery, surgeon noted the locking mechanism of the screw was opened.This record represents 1 of 2 screws.
Event or Problem Description
It was reported that a mesa small stature deformity polyaxial screw, implanted in l1, disengaged post-operatively.During revision surgery, surgeon noted the locking mechanism of the screw was opened.This record represents 1 of 2 screws.
Additional Manufacturer Narrative
Correction: updated from 'stryker spine- leesburg' to 'k2m, inc.' during visual inspection, it was observed that the screw was in the unlocked position.The screw head assembly and screw shaft were intact.There is no definitive evidence to confirm that the screw was locked.During functional inspection, the failure mode could not be replicated during functional testing.Device history records were reviewed for the provided lot number and no relevant manufacturing issues were identified as all units met stryker specifications.Complaint history databases were reviewed for the provided lot and one similar complaint was identified.Per surgical techinque: potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.Potential risks also include those associated with any spinal surgery resulting in neurological, cardiovascular, respiratory, gastrointestinal or reproductive compromise, or death.Postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.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.Loads produced by load bearing and activity levels will impact the longevity of the implant.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.Surgical implants must never be reused.An explanted metal implant should never be reimplanted.Even though the device appears undamaged, it may have small imperfections and internal stress patterns which may lead to early breakage.The root cause could not be determined.It is possible the screws were not fully locked, eventually unlocking during the seven month post-op period.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE 4.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8813644
• Report Number: 3004774118-2019-00073
• Device Sequence Number: 11164475
• Product Code: NKB
• UDI-Device Identifier: 10888857046320
• UDI-Public: 10888857046320
• Combination Product (Y/N): N
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3001-04540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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: Required Intervention
• Patient Weight: 40