MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. X90 PEDICLE SCREW SYSTEM

Model Number	N60000329
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The company received a package of broken pedicle screws and a broken rod in the mail.There were no complaint details received with the package.The company made multiple attempts to retrieve details regarding the returned hardware, necessary details to complete a complaint investigation were unable to be obtained.It is unknown if the damage occurred during removal.There were no known patient complications.Additional related part numbers and lot numbers are listed below.N60000329, lot# 153822; n60000318, lot# 183174; n60000319, lot# 159594; n60000329; lot# 180244; n60000328; lot# 177075; n60000305, lot# 3557-01.Dhr reviews were performed for each lot number.There were no manufacturing anomalies identified in the dhrs.The devices met all required specifications prior to being released to distributable inventory.
Event or Problem Description
The company received a package of broken pedicle screws and a broken rod in the mail.There were no complaint details received with the package.The company made multiple attempts to retrieve details regarding the hardware.There were no known patient complications.

• Brand Name: X90 PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 7843684
• Report Number: 3005031160-2018-00026
• Device Sequence Number: 16631894
• Product Code: MNI
• UDI-Device Identifier: M697N600003291
• UDI-Public: M697N600003291
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N60000329
• Device Lot Number: 153822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other