MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PLUG; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 2000-1005

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 09/26/2019

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.Reference reports 3012447612-2019-00499 to 3012447612-2019-00511.[mw5090393].

Event Description

It was reported that a patient underwent a revision surgery where eight plugs, two rods, two screws, and one cross connector were removed.It was reported that two screws were fractured.No further surgical information or additional patient impacts were reported.This is report seven of thirteen.

Event Description

No new information.

Manufacturer Narrative

Additional information: h6.(device codes, methods, results, conclusions).(pce80791: pn2000-24xx).The complaint is confirmed for 2 (two) of 2 (two) unreturned polaris 5.5 titanium screw (pn 2000-24xx) for the reported failure of fracture.The severity of this event is 3 (rmr-00090).Without further information, the cause of this failure cannot be determined.It is possible that the patient underwent a traumatic incident (such as a fall) which led to this event.However, no information was provided to indicate this.-no other defects could be determined for the remaining item numbers 2000-1005, 2000-51xx, 9467x.-the lot numbers were not provided, so the dhr's are unable to be reviewed.-review of complaint history for pn 2000-24xx identified 1 additional complaint for the same part number for the same or similar issue.No complaint search was performed for pn 2000-1005, 2000-51xx, and 9467x as no defects were noted and the complaint was initiated for the issue of two fractured screws with pn 2000-24xx.-the devices are used for treatment.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.-no medical records were provided for review.-a definitive root cause cannot be determined.-no action is recommended at this time.

• Brand Name: PLUG
• Type of Device: EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9387787
• MDR Text Key: 168441190
• Report Number: 3012447612-2019-00505
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2000-1005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR