MAUDE Adverse Event Report: SEASPINE INC. CORAL ROD ¿ UNSPECIFIED; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number XXX-CORAL IMPLANT

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 11/04/2015

Event Type  malfunction  

Event Description

There are 7 submissions associated with this event: one patient, two procedures (initial and revision), 5 devices.The initial complaint was made against one product, 3 lots.Mfr report numbers for 7 submissions - 2032593-2015-00024; 2032593-2015-00026; 2032593-2015-00027; 2032593-2016-00001; 2032593-2016-00002; 2032593-2016-00003; 2032593-2016-00004.This is report 7 of 7.Initial information reported: it was reported a revision surgery was required due to the device issue.On (b)(6) 2015 the patient underwent a revision procedure for an interbody implant that had migrated postoperatively from the initial procedure 9 weeks prior.During the revision procedure the surgeon noticed that the rods on each side of the construct were loose and could translate within the pedicle screw tulip.This was due to the loosening of the locking caps.The interbody was removed and the construct was stabilized.In response to repeated requests for confirmation of devices used and circumstances of event, it was later reported: " a ventura interbody was what migrated.The height of which is currently unknown.A coral screw construct was used to stabilize the spine.Therefore, coral pedicle screws were removed along with coral locking screws and rods.Then the migrated interbody was removed.I do not know what the surgeon used to re-instrument the spine in order to stabilize spine in the revision procedure.".

Manufacturer Narrative

There was a single event in which seven medwatch submissions were filed conservatively as there was no single/direct allegation on an individual concomitant product used during initial surgery.No serial radiographs were received and the event could not be confirmed.The report alleges that a revision surgery was performed to remove the peek cage that had migrated and it was discovered that the posterior fixation was loose.It is unknown if the cage migrated and created uneven loading on the posterior fixation causing it to loosen, or if the construct loosened creating instability causing the cage to migrate.It is unknown what was put in place of the explanted cage.The posterior fixation was reportedly stabilized.The explant was discarded by the hospital.No product will be returned, no product information was given, and no further evaluation of the product can be completed at this time.Patient activity at the time or prior to the event is unknown.Patient's bone quality is unknown.The degree of spinal instability is unknown.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.Care should be taken to insure that all components are ideally fixated prior to closure.The root cause of this reported event has not been determined, no conclusion can be drawn.Review of labeling notes: warning cautions and precautions "loosening, bending, dislocation, and/or breakage of the components, possibly requiring further surgery".

• Brand Name: CORAL ROD ¿ UNSPECIFIED
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 5366525
• MDR Text Key: 35964830
• Report Number: 2032593-2016-00004
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041592
• 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: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: XXX-CORAL IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: CORAL LOCKING SCREWS
• Patient Outcome(s): Required Intervention