MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ELEVATE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 7770723

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

Pre-operative diagnosis : lumbar canal stenosis procedure: transverse lumbar interbody fusion it was reported that during surgery, a part of the cage broke upon insertion at l5/s1.Fragments were secured and removed.There was an delay of less than 60 min in overall procedural time.No patient complications were reported as a result of the event.

Manufacturer Narrative

Product analysis: the spacer was returned with one ear of component -03 broken off and the other bent.There is an area of deformation on the corner of the tip of component -03 where appears this component was impacted.There is a witness mark on the back side of component -01 where it appears that the instrument came in contact with the implant.The fracture face is consistent with a brittle fracture from overload.This appears to be from the implant nose impacting a hard surface during installation.The spacer was completely closed when returned.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ELEVATE SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7034131
• MDR Text Key: 92516670
• Report Number: 1030489-2017-02336
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169430433
• UDI-Public: 00643169430433
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7770723
• Device Lot Number: 0516167W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1