MAUDE Adverse Event Report: SPINECRAFT APEX SPINE SYSTEM; ROD

Model Number	6000-300D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no known injury to the patient or any loss of the deformity correction achieved during surgery.The devices involved were all manufactured by spinecraft and met specification requirements.Complaint trend analysis found no other early breakage complaints to have been reported for ø6.0 mm titanium rods.A review of the device history record of the specific lot used cannot be completed without lot number information since the device has not been explanted.Provided images were examined but no conclusions could be made.Breakage can occur due to delayed union or non-union as well as with cyclical loading of the device over time.Notches, scratches or excessive contouring of the implant during the course of surgery may also contribute to early failure.A follow up report will be filed if a revision surgery is performed and additional information obtained.
Event or Problem Description
Approximately 3 months post-op, patient experienced a "pop" in her back and complained of some discomfort.X-rays reveals that one of the ø6.0 mm titanium rods in the lumbar region is fractured.However, there was no loss of alignment and no substantial pain.At this time, there is no revision surgery scheduled, and the devices remain implanted.Patient will continue to be monitored by the surgeon.It is reported that revision surgery is to be considered if there is a loss of alignment during subsequent follow up visits.
Additional Manufacturer Narrative
As of today, the explants were not returned for evaluation.Therefore, we are unable to determine a definitive cause of the reported event.Several factors may have contributed to the rods fracture.The labeling was reviewed and found to contain sufficient post-operative instructions to be provided to the patient.A supplemental report is not anticipated unless the explants are returned.Should the product become available, a physical evaluation will be conducted and a supplemental report will be filed with the results.
Event or Problem Description
No revision surgery was performed after the first titanium rod broke.About 6 weeks later the second titanium rod broke.A revision surgery was performed after the second rod fractured and both 6.0 mm titanium rods were replaced with 6.0 mm cocr rods.This is a follow up report for this event.

• Brand Name: APEX SPINE SYSTEM
• Common Device Name: ROD
• Manufacturer (Section D): SPINECRAFT; 777 oakmont lane, suite # 200; westmont 60559 5511
• MDR Report Key: 6777248
• Report Number: 3004717358-2017-00002
• Device Sequence Number: 1602202
• Product Code: NKB
• UDI-Device Identifier: M8246000300D1
• UDI-Public: +M8246000300D1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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: No Information
• Device Model Number: 6000-300D
• Device Catalogue Number: 6000-300D
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: A5P-7050; A5P-7050R
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 86