MAUDE Adverse Event Report: BIOMET SPAIN, S.L. OMEGA21 SPONDY S/T SCR 6.35X55

Model Number N/A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.The necessary manufacturing history was not provided for review.Current information is insufficient to permit a conclusion as to the cause of the event.The following could not be completed with the limited information provided: date of event - unknown, type of device - unknown, device info - expiration date unknown, manufacture date ¿ unknown.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet manufactures a similar device (pedicle screw).This report is number 2 of 2 mdrs filed for the same patient (reference 3002806535-2016-00005 & 00006).Product location unknown.

Event Description

It was reported that the patient underwent a reduction of the vertebral body due to olisthesis on an unknown date.During reduction, two screws fractured.As a result, both screws were removed and replaced with additional screws.Due to the event there was a delay in procedure of twenty (20) minutes.

• Brand Name: OMEGA21 SPONDY S/T SCR 6.35X55
• Manufacturer (Section D): BIOMET SPAIN, S.L.; calle islas baleares, #50; fuente del jarro; valencia 46988 ; SP 46988
• Manufacturer (Section G): BIOMET SPAIN, S.L.; calle islas baleares, #50; fuente del jarro; valencia 46988 ; SP 46988
• Manufacturer Contact: ricardo toribio ; calle islas baleares, #50; fuente del jarro; valencia 46988 ; SP 46988 ; 0349613795
• MDR Report Key: 5556238
• MDR Text Key: 42198187
• Report Number: 0009610576-2016-00006
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 1287-55
• Device Lot Number: 2016044679
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention