MAUDE Adverse Event Report: ZIMMER SPINE 7.5X35MM INSTINCT JAVA POLYAXIAL SCREW; INSTINCT JAVA SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.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.

Event Description

A java pedicle screw system was implanted on (b)(6) 2014 after removal of a sherpa system.On (b)(6) 2018, the entire java system was removed due to one screw that broke under the collar of the tulip and was causing the patient pain.The body of the screw was unable to be removed from the patient and remains implanted.Nothing else was implanted since the vertebrae had already fused.

Event Description

A java pedicle screw system was implanted on (b)(6) 2014 after removal of a sherpa system.On (b)(6) 2018, the entire java system was removed due to one screw that broke under the collar of the tulip and was causing the patient pain.The body of the screw was unable to be removed from the patient and remains implanted.Nothing else was implanted since the vertebrae had already fused.

Manufacturer Narrative

Udi number: na.Additional information in ethnicity, udi number, concomitant medical products, method, results, and conclusions codes.The returned portion of the screw was evaluated.The shaft was found to have fractured at the last thread due to cyclic loading.The cause cannot be determined.A review of the device labeling found that the device may be removed after fusion has occurred.The production records were reviewed; there were no issues identified which would have contributed to this event.

• Brand Name: 7.5X35MM INSTINCT JAVA POLYAXIAL SCREW
• Type of Device: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux 33080 ; FR 33080
• MDR Report Key: 7857804
• MDR Text Key: 119641005
• Report Number: 3003853072-2018-00086
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: PK111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 046W0AN27535
• Device Lot Number: H17600D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 105