MAUDE Adverse Event Report: SPINECRAFT ASTRA SPINE SYSTEM; ROD

Catalog Number	A5RR-Z55-300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken diameter 5.5mm z-rod was explanted during the revision surgery and replaced with a larger diameter rod (diameter 6.0mm).The explanted rod was returned to spinecraft for evaluation, which allowed us to confirm the exact lot number and conduct a thorough review of the device history record.No deviations or anomalies were identified.Complaint trend analysis found no other similar issues to have been reported for diameter 5.5mm or diameter 6.0mm titanium z-rods.The usage history review for this lot showed that 28 rods out of total of (b)(4) manufactured have been used in surgeries to date with no issues reported.The returned product was also visually evaluated but no conclusions could be made.Additionally, pre-operative x-ray images were received and reviewed; the images showed that no bony fusion is evident at the level where this z-rod was used.Based on the above information collected and reviewed, it has been concluded that this rod breakage likely occurred due to non-union and cyclical loading over time.This is a known inherent risk associated with metallic implants where if bony fusion is delayed, or does not occur, the implant may eventually break due to metal fatigue.And this risk is specified in our instructions for use (ifu).Additionally, from the investigation it has been identified that there has been no issue in the manufacturing or release of the device that could have contributed to the problem reported.
Event or Problem Description
Approximately 16 months post-operatively, the patient was revised for a broken diameter 5.5mm titanium z-rod.

• Brand Name: ASTRA SPINE SYSTEM
• Common Device Name: ROD
• Manufacturer (Section D): SPINECRAFT; 777 oakmont lane, suite # 200; westmont, il
• MDR Report Key: 9886956
• Report Number: 3004717358-2020-00001
• Device Sequence Number: 14167483
• Product Code: NKB
• UDI-Device Identifier: 00193082057229
• UDI-Public: 010019308205722910112980
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: A5RR-Z55-300
• Device Lot Number: 112980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/26/2020
• 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: Required Intervention
• Patient Age: 62 YR