MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS TITANIUM TRANSITION ROD D6XL600 ROW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48573608

Device Problems Shelf Life Exceeded (1567); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2015

Event Type  malfunction  

Event Description

The sales rep reported that the surgeon implanted an out of date implant.The surgeon was undertaking a procedure involving implantation of taper transition rods and realised that there were insufficient implants in the consigned kits for the procedure.At short notice, the representative arranged for additional taper rods to be couriered from another hospital.The devices sent had passed their expiry date.The staff at the receiving missed the fact that these devices were out of date and implanted them.Surgery was completed successfully.

Manufacturer Narrative

Method: complaint history review; risk assessment; results: the packaging in the provided pictures does not appear to be that of stryker origin.Implants are loaded into containers and sent out to the field and it is the responsibility of each end user to sterilize the implants as per specified by the ifu.Conclusion: there is no product issue as the parts were sterilized per the ifu and local procedures.

Event Description

The sales rep reported that the surgeon implanted an out of date implant.The surgeon was undertaking a procedure involving implantation of taper transition rods and realised that there were insufficient implants in the consigned kits for the procedure.At short notice, the representative arranged for additional taper rods to be couriered from another hospital.The devices sent had passed their expiry date.The staff at the receiving missed the fact that these devices were out of date and implanted them.Surgery was completed successfully.

• Brand Name: OASYS TITANIUM TRANSITION ROD D6XL600 ROW
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5161799
• MDR Text Key: 29037650
• Report Number: 0009617544-2015-00449
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48573608
• Device Lot Number: 8997977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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