MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE SCREW, UNKNOWN SIZE

Device Problems Flaked (1246); Biocompatibility (2886)

Patient Problems Pain (1994); Reaction (2414)

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 3012447612-2018-00954 thru 3012447612-2018-00971.Mw5080455.

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 nine of eighteen for this event.

Manufacturer Narrative

Additional information: results and conclusions - the screw was not returned and the device's identity is not available, so an evaluation is unable to be performed.The components are made of titanium in most pedicle screws.However, there are some components made out of cobalt chrome for the translating screws.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 nine of eighteen for this event.

• Brand Name: PEDICLE SCREW, UNKNOWN SIZE
• 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: 8111653
• MDR Text Key: 128636268
• Report Number: 3012447612-2018-00962
• Device Sequence Number: 1
• Product Code: HWC
• 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