MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 1 LEVEL ACP SIZE 14MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 48651114

Device Problems Device Slipped (1584); Material Deformation (2976)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 06/28/2016

Event Type  Injury  

Event Description

It was reported that; on (b)(6) 2014, primary surgery was performed.After that, a screw backout was found in regular post op visit.Then an extraction surgery of all the implant was performed on (b)(6) 2016.

Manufacturer Narrative

Method: visual analysis, device history review, complaint history review, risk assessment.Result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The stryker rep was unable to obtain any additional information on the case.A possible root cause of this device failure could stem from patient activity, however, this could not be confirmed by the stryker rep.Another possible cause of failure is fatigue of the device, due to the length of implantation, as the device was implanted long enough to allow the patient to fuse.This is the intention of the device; therefore, the device can be removed, as the presence of the device is no longer required, as stated in the referenced instructions for use (referenced in labelling review).As the device was implanted for approximately two years, the device would have undergone normal loading cycles and fatigue, which could have contributed to the device failure; the instructions for use.Conclusion: the plausible root cause cannot be confirmed; therefore, the root cause is not determined and is multi-factorial.

Event Description

It was reported that; on (b)(6) 2014, primary surgery was performed.After that, a screw backout was found in regular post op visit.Then an extraction surgery of all the implant was performed on (b)(6) 2016.

• Brand Name: REFLEX-HYBRID 1 LEVEL ACP SIZE 14MM
• Type of Device: SPINAL INTERVERTEBRAL BODY 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5821008
• MDR Text Key: 50388084
• Report Number: 0009617544-2016-00300
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 04546540534729
• UDI-Public: (01)04546540534729
• Combination Product (y/n): N
• PMA/PMN Number: K040261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48651114
• Device Lot Number: 140582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2014
• 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): Required Intervention
• Patient Age: 61 YR