MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. UNKNOWN ARRAY PEDICLE SCREW; EBI ARRAY SPINAL SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Inadequate Osseointegration (2646)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Reference report (b)(4).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.

Event Description

It was reported that two screws broke at s1 bialaterally.Over time, the fusion did not heal properly which caused the screws to break.An adjacent level fusion was done.The two screws were left in the patient since the physician could not get a good angle on them.Two new screws were added and original caps were used to complete the case.This is report one of two for this event.

Event Description

It was reported that two screws broke at s1 bilaterally after being implanted for approximately 17 years.A revision surgery was performed, however, the surgeon was unable to get the proper angle to remove the screws so left them implanted.The adjacent level was added to the construct.X-ray evaluation by the manufacturer found two set screws had also backed out.The set screws were retightened in the screws during the revision surgery.This is report one of four for this event.

Manufacturer Narrative

Additional information.H6: type of investigations, findings, and conclusions.Device evaluation: the screws were confirmed to have fractured by reviewing the provided x-ray.Potential cause root cause was unable to be determined.This event could possibly be attributed to the fusion not healing properly, as stated by the complainant.Dhr review and related actions lot number is not known, so a dhr review could not be performed.Device usage this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference reports 3012447612-2021-00169-1, 3012447612-2021-00170-1, 3012447612-2021-00222, and 3012447612-2021-00223.

• Brand Name: UNKNOWN ARRAY PEDICLE SCREW
• Type of Device: EBI ARRAY SPINAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11815434
• MDR Text Key: 250362489
• Report Number: 3012447612-2021-00169
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K061563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention