MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD POL 6.35 TI XS CROSS CONNECTOR; SYNERGY D2 SPINAL IMPLANTS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Information (3190); No Code Available (3191)

Event Date 10/11/2013

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.Report four of four for the same event; see also 3004485144-2016-00007 through 00009.

Event Description

Legal counsel for patient reported that patient had initial spinal surgery with biomet products.Patient's legal counsel further reports corrective surgery was performed.No further allegations received at this time.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

Reference reports 3004485144-2016-00007 thru 3004485144-2016-00010, 3012447612-2017-00154 thru 3012447612-2017-00157, and voluntary report mw5068372.

Event Description

It was reported that a revision surgery was performed to address pseudoarthrosis at levels t12-l1 and l2-l3.Information from voluntary medwatch mw5068372 states that the revision also addressed cap screws which were not tight, followed by screws which were loose, followed by broken rod, and an infection.This is report four of eight for this event.

• Brand Name: POL 6.35 TI XS CROSS CONNECTOR
• Type of Device: SYNERGY D2 SPINAL IMPLANTS
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5417509
• MDR Text Key: 37714180
• Report Number: 3004485144-2016-00010
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK984578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• 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: 6650
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• 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: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 18 YR