MAUDE Adverse Event Report: ZIMMER SPINE VERROU; BLOCKER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/15/2015

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.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.

Event Description

It is reported during clinic follow up on (b)(6) 2015, an x-ray revealed the screw at left lumbar 4 was broken.During another follow up on (b)(6) 2015 it was noted that the screw on right lumbar 4 was also fractured.The hardware was removed on (b)(6) 2015 and on (b)(6) 2015 the patient underwent an anterior lumbar fusion with instrumentation.Patient symptom prior to discovery was low back pain.The patient's fusion status at the time of removal was non-union.For the original surgery the patient's indications were the following: lumbar 4-5 instability, lumbar 4-5 posterior decompression, interbody fusion, instrumentation.

Manufacturer Narrative

Based on the reported complaint and visual evaluation of the returned device, no additional evaluation will be performed on this device as there is no reported failure of this device or visual damage identified.Supplemental report two of two for the same event, reference 3003853072-2015-00013-3.

• Brand Name: VERROU
• Type of Device: BLOCKER
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; bordeaux 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; bordeaux 33080 ; FR 33080
• Manufacturer Contact: 23 parvis des chartrons; bordeaux 33080
• MDR Report Key: 5460929
• MDR Text Key: 39041825
• Report Number: 3003853072-2016-00010
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• 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: 046W0AN00002
• Device Lot Number: E83339
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 147