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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Inadequate Osseointegration (2646)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

There were no reports of device malfunction, however the manufacturer found the set screw had backed out of the mating screw when reviewing the provided x-ray.The cause cannot be determined with the available information.But, this event could possibly be attributed to the fusion not healing properly, as stated by the complainant.The lot number is unknown, so the dhr is unable to be reviewed.This device is used for treatment.If any information is received which changes the information in the report, a follow-up report will be submitted.Reference reports 3012447612-2021-00169-1, 3012447612-2021-00170-1, 3012447612-2021-00222.

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 four of four for this event.

• Brand Name: ARRAY SET SCREW, UNKNOWN TYPE
• Type of Device: EBI ARRAY SPINAL SYSTEM
• 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12069657
• MDR Text Key: 258447419
• Report Number: 3012447612-2021-00223
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1