MAUDE Adverse Event Report: PRECISION SPINE, INC TLIF CAGE PEEK 12MM X 30MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number TLIF30-12P

Device Problems Break (1069); Crack (1135); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Retained foreign object due to the inability to remove a small piece of the peek cage that broke off.Engineering evaluation of the returned product confirms the broken edge but the complaint component also exhibits a crack thru one of the implant walls.It is not clear from the complaint if the wall fractured during insertion or removal or if this fracture was a result of some post-operative event since this observation was not noted in the complaint.The cause for the reported breakage in the area around the thread is unknown but is likely due to an overload condition being encountered during implantation.The breakage around the thread and the complaint information indicate that the inserter was connected to the implant at the time of the breakage.The location of the thread breakage and the wall breakage indicate that a bending moment was likely applied to the implant with the inserter still in place.Review of manufacturing history records found a total of (b)(4) pieces of lot 1067ps released for distribution on 1/23/2014 with no deviation or anomalies.Complaint history review did not reveal any previous reports of this nature for this lot.A trend for reports of this nature was not identified.As the root cause is likely attributed to surgical technique, and the failure rate remains low, the need for corrective action was not indicated.

Event Description

It was reported that during a procedure performed in the (b)(6), the disc space was carefully prepared and the cage was assembled onto the inserter.Upon insertion of the tlif cage peek 12mm x 30mm (tlif30-12p) a crack was heard and the cage was removed, at which time it was noted that the cage had broken at the edge of the threaded hole where the inserter assembles.A small piece of the broken cage was left in the disc space as it was too small to retrieve.Another cage of the same size was readily available and was successfully implanted without any additional preparation.A delay to the procedure of 5 minutes resulted.

• Brand Name: TLIF CAGE PEEK 12MM X 30MM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: beth albert ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 5748427
• MDR Text Key: 48131317
• Report Number: 3005739886-2016-00031
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: K080314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2016

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
• Device Operator: Physician
• Device Catalogue Number: TLIF30-12P
• Device Lot Number: 1067PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2014
• 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 Outcome(s): Other