MAUDE Adverse Event Report: IMPLANET JAZZ; MULTI-PURPOSE SPINE CONNECTOR

Catalog Number 350150

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

The review of the batch record did not show any non conformity.The products are conform to implanet specifications.

Event Description

Initial surgery : (b)(6) 2015.Patient returned to surgeon two years after the initial surgery, complaining of discomfort.It was determined that screws at s1 had pulled out and that the two most proximal jazz bands implanted had broken.The surgeon extended the construct up two levels to t6 and down a level to the pelvis.It should be noted that the two jazz that broke were implanted at the proximal end of the construct without support of screws.

• Brand Name: JAZZ
• Type of Device: MULTI-PURPOSE SPINE CONNECTOR
• Manufacturer (Section D): IMPLANET; technopole bordeaux montesquie; allee francois magendie; martillac, 33650, fr
• Manufacturer (Section G): IMPLANET; technopole bordeaux montesquie; allee francois magendie; martillac, 33650, fr
• Manufacturer Contact: régis le couëdic ; allee francois magendie; technopole bordeaux montesquie; martillac, france 33650 ; 0033357995
• MDR Report Key: 6307077
• MDR Text Key: 67116086
• Report Number: 3007675554-2017-00001
• Device Sequence Number: 1
• Product Code: OWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 350150
• Device Lot Number: DROZ0016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR