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 10/27/2015

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 the patient was scheduled for a revision of fusion from l4-5, l5-s1 for psuedoarthrosis and extension of fusion to l3-4.While removing the sacral screw on the left side it was noted to be broken.The patient had an x-ray in (b)(6) and a ct scan in (b)(6); the screw was not identified to be broken in the x-ray or the ct scan.The patient states he was on a long road trip in (b)(6) and hit several bumps or depressions in the road.He reports having immediate onset of back pain that consequently worsened into severe pain, and numbness with weakness in his thighs.Patient's original surgery indications were as follows: stenosis at lumbar 4-5, lumbar 5-sacral 1 stenosis with instability at l4-5 with neurogenic claudication.Lumbar 4-5, lumbar 5-sacral 1 posterior decompression, interbody fusion and instrumentation.Explant and replace hardware with additional level, lumbar 3-4, due to junctional instability.Lumbar 3-4, 4-5, lumbar 5-scaral 1 alif on day two.Patient was discharged in stable condition on day two.

Manufacturer Narrative

Based on the reported complaint and visual evaluation of the returned device, no additional evaluation will be performed as there is no reported failure of this device or visual damage identified.Supplemental report three of three for the same event, reference 3003853072-2015-00017-3 and 3003853072-2016-00013-1.

• 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: 5460554
• MDR Text Key: 39027313
• Report Number: 3003853072-2016-00014
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

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: 046W0AN00002
• Device Lot Number: E83355
• 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
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2016
• 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: 54 YR
• Patient Weight: 108