MAUDE Adverse Event Report: ALPHATEC SPINE INC REDUCTION SCREW EXTENDER (STAINLESS STEEL); LXH

Model Number 73772

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

The irregularity begins approximately.100" from the distal tip and travels up at a slight angle then back down to the.225 rod channel.The detached fragment which was removed from the patient, is approximately.099" in width by.240" long and manufactured from (b)(4) (stainless steel) which is processed and certified to astm a564 specifications.Examination of the fractured surface shows a flake of material partially removed from the surface.This is indicative of ductile fracture.The fractured surface does not appear to have experienced a fatigue failure.The direction of the flake of material indicates that a lateral force was applied to cause the failure.There was no indication of wear or gouging on the device surfaces.The lack of wear patterns or gouging on the surface of the device indicates that the device was not damaged in such a way to create a stress concentration or weak point on the device.The device most likely failed due to excessive lateral force put on the distal engagement tip.This excessive force may have been imparted directly to the device during manipulation or removal during surgery or by an improper attachment to the screw.If the screw was improperly attached, forces on the device would be transferred to the implant engagement surfaces.The international customer ((b)(6) ) explained what is meant by partial anesthesia.The area of extraction was numbed for removal.The patient was not put to sleep.

Event Description

The initial surgery was performed on (b)(6) 2017.After the surgery while reviewing the ct and mri films ((b)(6) 2017), the surgeon noticed that there was a substance located at the s1.He decided to do a removal surgery, which was conducted with a partial anesthesia the next day (b)(6) 2017.

• Brand Name: REDUCTION SCREW EXTENDER (STAINLESS STEEL)
• Type of Device: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, CA 92008 ; 7604946842
• MDR Report Key: 7205601
• MDR Text Key: 98092001
• Report Number: 2027467-2017-00096
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2017

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
• Device Operator: Physician
• Device Model Number: 73772
• Device Catalogue Number: 73772
• Device Lot Number: 6621201S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other