MAUDE Adverse Event Report: SPINECRAFT ASTRA SPINE SYSTEM; A5P-8580

Catalog Number	A5P-8580
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The screw explanted after the revision surgery was returned to spinecraft and investigation was performed.Bench testing was conducted on several screws from or associated with the same components used in incident lot to challenge the assembly.All screws were able to withstand over 21 nm tightening torque of their set screws, which is double the set screw normal tightening torque, without disengagement of the screws heads (tulips).The usage history was also reviewed for this lot of the screws and this showed that no incident has been reported in regard to this lot or other lots using components associated with the same.Multiple representative lots of assembly components associated with the explanted screw were re-inspected and no deviations were found.A thorough review of the device history record was performed and no deviations or anomalies were identified.The tolerance analysis for design was also reviewed and no faults were found.The root cause of the reported failure cannot be determined at this time as there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported.We can presume however that load force exceeding the load capacity of the screw was probably encountered post-op, with the subsequent failure of the bottom ring.If additional information became available a supplemental report will be filed accordingly.
Event or Problem Description
It was found two weeks post-op on x-ray that an iliac screw head at the bottom of a long construct was disengaged from the shaft.The surgeon decided to perform a revision surgery at a later date.

• Brand Name: ASTRA SPINE SYSTEM
• Common Device Name: A5P-8580
• Manufacturer (Section D): SPINECRAFT; 777 oakmont lane, suite # 200; westmont 60559 5511
• MDR Report Key: 7937073
• Report Number: 3004717358-2018-00002
• Device Sequence Number: 930194
• Product Code: NKB
• UDI-Device Identifier: M824A5P85801
• UDI-Public: M824A5P85801
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K150417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A5P-8580
• Device Lot Number: 111032
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR