MAUDE Adverse Event Report: ZIMMER SPINE INSTINCT JAVA; TRANSPEDICULAR FIXATION SYSTEM

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

The implant part numbers (screw and rod) are unknown at this time.Without a product return, no product evaluation is able to be conducted.The user facility is foreign; therefore a facility medwatch report will not be available.Current information is insufficient to permit a valid conclusion about the cause of this event, however based on the information available the system being improperly implanted during the initial surgery.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report two of three for the same event, reference 3003853072-2016-00087 and 3003853072-2016-00090.

Event Description

A revision surgery due to neuralgia was reported.X-ray examination showed that one of the screws was improperly installed and entered the spinal canal.During the revision surgery while attempting to remove the blockers two final screwdrivers broke.The broken parts were removed using general instruments.The surgery was completed using a third final screwdriver.The surgeon reimplanted the same screw.There was a thirty (30) minute surgical delay.

• Brand Name: INSTINCT JAVA
• Type of Device: TRANSPEDICULAR FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux 33080 ; FR 33080
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047419468
• MDR Report Key: 5765095
• MDR Text Key: 48652473
• Report Number: 3003853072-2016-00089
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2016

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention