MAUDE Adverse Event Report: K2M. INC EVEREST SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 2901-10001

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That post-operatively two screws migrated out of the tulip head of a uniplanar screw at the distal end of the construct, causing displacement of the rod and loss of correction.The patient was revised on (b)(6) 2018.

Event Description

On 09.28.2018 it was reported to k2m, inc.That post-operatively two set screws migrated out of the tulip head of a uniplanar screw at the distal end of the construct, causing displacement of the rod and loss of correction.The patient was revised on (b)(6) 2018.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation, and a thorough investigation was completed.All records revealed that product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.Upon review of the set screws, it was observed that three of the screws displayed radial damage consistent with the effects of reduction of the rod during tightening of the set screw.This maneuver can lead to less than optimal engagement between the tulip head and the rod, and therefore more pressure on the distal face of the set screw.This pressure, when coupled with non-compliance and movement of the patient, can allow the set screws to back out of the retaining head.

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 8009515
• MDR Text Key: 125149793
• Report Number: 3004774118-2018-00156
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

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: GEMU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 09/28/2018
• Supplement Dates FDA Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2901-B60500 LOT FWVG; 2901-B60500 LOT FWVG; 2911-36550 LOT DAXX; 2911-36550 LOT GJXJ; 2911-37555 LOT CBKX; 2901-B60500, LOT FWVG
• Patient Outcome(s): Required Intervention
• Patient Weight: 119