MAUDE Adverse Event Report: MSD DEGGENDORF MFG CRESCENT SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 9393009INT

Device Problem Crack (1135)

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

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Device evaluation anticipated, but not yet begun.

Event Description

It was reported that a patient underwent interbody fusion using peek cage.During cage insertion, a cage was cracked at the connection of inserter.The surgical time was extended less than 15 min as a result of the event.The device was used in the patient.No patient complications were reported as a result of this event.Product broke while it was being inserted.A new cage was used.No fragment was left in the patient.

Manufacturer Narrative

Product analysis: macroscopic examination confirms the implant is fractured into multiple pieces and broken.Lot number could not be verified, due to that portion of the implant was not returned for analysis.Some of the broken off pieces are missing and not returned for analysis.The extent of the damage, as well as the area of fracture initiation at the inserter attachment point suggests significant force was utilized during the attempted insertion.Optical examination of the fracture surfaces identified morphology consistent with brittle overload during insertion as the mechanism of failure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRESCENT SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5136279
• MDR Text Key: 28155889
• Report Number: 1030489-2015-02597
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K094025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Catalogue Number: 9393009INT
• Device Lot Number: 59AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1