MAUDE Adverse Event Report: SEASPINE INC. POLYAXIAL SCREW-SOLID 6.5X45MM

Catalog Number 18-12-6545

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

This report is about a (b)(6) patient, 4 years post operated of a transforaminal lumbar interbody fusion (tlif) and doing fine.The patient began to have adjacent segment disease l3-l4.Upon evaluating him for his new symptoms it was discovered via radiograph that the right l4 tulip had disassociated from the bone screw shank.Patient was asymptomatic with regards to previous fusion s1- l4.Exact date unknown, but discovery of the event was (b)(6) 2015.Primary treatment to fuse l4 to s1 was successful.Revision included extending hardware from s1 to l3, but skipping construct at l4 as the pedicle bone screw was encased in bone.Revision completed without issue.No reported delay in surgery.

Manufacturer Narrative

Radiographs confirming the event were received.An investigation into the device history record notes no material non-conformances or manufacturing errors that may have caused or contributed to the reported event.There have been no other complaints reported against this lot.The returned subject part was measured and met specifications.Some areas of the part could not be measured due to damage.The tulip displays damage/material deformation at the tulip-shank connection in a manner that suggested the tulip disassociated from the shank at an angle, under a prying force.The collet marring inside the tulip suggests the pedicle screw was sufficiently locked down at the time of initial surgery.Additionally the radiograph confirmed the lock screw, tulip, and rod were still intact, suggesting the construct was properly fixated upon closure.No serial radiographs were received and with implantation of approximately five years duration, it is unknown at what time the failure occurred.The shank was not returned for evaluation as it remains in-situ and no further device investigation can be completed on the mating pedicle screw shank at this time.Anatomical stability, patient activity level, and patient's compliance with post-surgical instructions are unknown.It is unknown if the patient sustained some impact or fall contributing to the event.There are many biological and mechanical factors that affect the longevity of these devices including anatomical stability, patient activity level, and patient's compliance with post-surgical instructions.These internal fixation devices are load sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually disassemble, loosen, bend, or break.After reviewing the available information, the root cause of this reported event has not been determined and no conclusion can be drawn.

• Brand Name: POLYAXIAL SCREW-SOLID 6.5X45MM
• Manufacturer (Section D): SEASPINE INC.; 2302 la mirada dr.; 2302 la mirada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 2302 la mirada dr.; vista CA 92084
• Manufacturer Contact: peter perhach ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165681
• MDR Report Key: 5343294
• MDR Text Key: 35553700
• Report Number: 2032593-2015-00032
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

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 Catalogue Number: 18-12-6545
• Device Lot Number: W14826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 01/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR