MAUDE Adverse Event Report: K2M INC. NILE¿ ALTERNATIVE FIXATION SYSTEM; BONE FIXATION CERCLAGE, SUBLAMINAR

Catalog Number 5416-F03730-SG

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be 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)(6) 2019 it was reported to k2m, inc.That a revision surgery took place due to 3 mm band breakage approximately 1 month post-operatively.The patient was revised on (b)(6) 2019.

Manufacturer Narrative

It is possible that the patient's fracture in the l1 vertebrae could have contributed to the nile bands tearing.The screws that were placed in l1 vertebrae lost purchase due to the fracture, which could have caused instability in the construct.It is possible that the fracture could have led to an increased range of motion in the t12- l2 area which increased tension in the bands during motion/rotation.This increase in tension could have caused the bands to fray, eventually causing them to tear.Manufacturing records were reviewed, and no relevant issues were found.

Event Description

It was reported that two nile bands 3mm and two nile clamp assemblies had torn about 20 days post-operatively.These implants were not available for inspection.The patient had gone to the er for reported pain.It was discovered from x-rays taken at the er that the patient had a fractured her l1 vertebral body through to the pedicle.This event resulted in a revision surgery which took place on (b)(6) 2019.In the revision surgery, the two nile bands were found to be torn.

• Brand Name: NILE¿ ALTERNATIVE FIXATION SYSTEM
• Type of Device: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8266339
• MDR Text Key: 133708284
• Report Number: 3004774118-2019-00003
• Device Sequence Number: 1
• Product Code: OWI
• Combination Product (y/n): N
• PMA/PMN Number: K143350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5416-F03730-SG
• Device Lot Number: GCJA-31890
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5401-85500-G2 LOT GDXN QTY 2
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 68