MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PLATE, UNKNOWN TYPE

Device Problems Flaked (1246); Biocompatibility (2886)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Udi number: na.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 3012447612-2018-00954 thru 3012447612-2018-00971.[mdr mw5080455.Pdf].

Event Description

It was reported that a patient has experienced a metal allergy, implant metal flaking, and pain post-operatively.The construct remains implanted.This is report sixteen of eighteen for this event.

Manufacturer Narrative

Additional information: results and conclusions - the complaint eludes to the polaris 5.5 product system being used, but this system does not contain any plates.It is possible that the polaris cross-connectors are actually being referenced, but this cannot be determined without further information.The plate (or cross-connector) was not returned and the device's identity is not available, so an evaluation is unable to be performed.The components of all polaris 5.5 cross-connectors are made of titanium.Since the device identity is unknown, the dhr is unable to be reviewed and there are no clear indications that this device may have contributed to the alleged event.The root cause is unable to be determined with the available information.

Event Description

It was reported that a patient has experienced a metal allergy, implant metal flaking, and pain post-operatively.The construct remains implanted.This is report sixteen of eighteen for this event.

• Brand Name: PLATE, UNKNOWN TYPE
• Type of Device: UNKNOWN
• 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: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8111721
• MDR Text Key: 128634081
• Report Number: 3012447612-2018-00969
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other