MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. X-LARGE OPEN POLY SCREW 540MM; NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118,

Catalog Number 2120-5540

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3012447612-2017-00242 thru 3012447612-2017-00248.

Event Description

It was reported that seven screws disassembled.No further information is available.This is report one of seven for this event.

Manufacturer Narrative

Additional information: the returned screw was evaluated.The tulip head was found disassociated from the shank of the screw; however, as no additional information concerning the event surrounding this failure was provided by the reporter, a cause cannot be definitively determined.A review of the manufacturing records found that all devices released from this lot did not display any issues which would have contributed to this event.

• Brand Name: X-LARGE OPEN POLY SCREW 540MM
• Type of Device: NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118,
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6668778
• MDR Text Key: 78554705
• Report Number: 3012447612-2017-00242
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2120-5540
• Device Lot Number: 68EL
• Other Device ID Number: (01)00889024332652
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1