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

Catalog Number	48651114
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	06/28/2016
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5821008
• Report Number: 0009617544-2016-00300
• Device Sequence Number: 18929077
• Product Code: KWQ
• UDI-Device Identifier: 04546540534729
• UDI-Public: (01)04546540534729
• Combination Product (Y/N): N
• PMA/510(K) Number: K040261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR