MAUDE Adverse Event Report: ZIMMER SPINE BLOCKER; INSTINCT JAVA SYSTEM

Catalog Number 046W0AN00002

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.Reference reports 3003853072-2019-00102 to 3003853072-2019-00111.

Event Description

It was reported that a patient underwent a revision surgery to remove an old java construct that was implanted years earlier.The complainant stated that there was no fusion present at the time of removal and a new construct was placed to complete the case.No further specific surgical or patient information was provided.This is report seven of ten.

Event Description

It was reported that a patient underwent a revision surgery to remove an old java construct that was implanted years earlier.The complainant stated that there was no fusion present at the time of removal and a new construct was placed to complete the case.No further specific surgical or patient information was provided.This is report seven of ten.

Event Description

It was reported that a patient underwent a revision surgery to remove an old java construct that was implanted years earlier.The complainant stated that there was no fusion present at the time of removal and a new construct was placed to complete the case.No further specific surgical or patient information was provided.This is report seven of ten.

Manufacturer Narrative

Additional information: h6 (results and conclusion).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.Insufficient information provided.Unable to perform a compatibility check.Complaint history review cannot be performed without product identification.A complaint history search was performed for item number 046w0an00002 and date greater than 12 months prior to notification date, utilizing view 20.Regulatory affairs ¿ audits/ auditor¿s view in etq.Data was filtered to remove duplicates from complaint number, item number, lot number and initial mdr report number.Data was then analyzed for relevance (tab 2).Review of complaint history for item # 046w0an00002 identified 0 additional complaints.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: BLOCKER
• Type of Device: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 9258585
• MDR Text Key: 180024338
• Report Number: 3003853072-2019-00108
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 046W0AN00002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention