MAUDE Adverse Event Report: K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION EVEREST® SPINAL SYSTEM; ORTHOSIS SPINAL FIXATION

Catalog Number 2901-10001

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has been returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(4) 2019 it was reported to k2m, inc.That a set screw backed-out, loosened or disengaged approximately 24 months post-operatively.Patient was revised on (b)(6) 2019.(related to 3004774118-2019-00013).

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint the set screw exhibited signs of use, including abrasions along the superior face and threads.A radial wear pattern was present on the inferior surface of the implant, indicating that the rod may not have been fully reduced into the screw head during final tightening.Improper reduction may result in dynamic motion within the assembly, leading to failure post-operatively.

Event Description

On (b)(6) 2019 it was reported to k2m, that a set screw backed, loosened disengage approximately 24 month post-operatively.Patient was revised on (b)(6) 2019.(related to 3004774118-2019-00013).

• Brand Name: EVEREST® SPINAL SYSTEM
• Type of Device: ORTHOSIS SPINAL FIXATION
• Manufacturer (Section D): K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8381519
• MDR Text Key: 137513301
• Report Number: 3004774118-2019-00014
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 2901-10001
• Device Lot Number: FGGV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2911-06550 LOT FNYJ; 299-06550 LOT FNYJ; 299-06550, LOT FNYJ
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 73