MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 2 LEVEL ACP SIZE 34MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48651234
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/15/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an implant failure and subsidence of cervical grafts.The screws on the cervical plate backed out of the supposedly locked.The device was removed and replaced with non-stryker cervical plate.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: the reported event was confirmed by the provided x-rays.Device was not returned.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the plausible root cause of the reported event is not determined.
Event or Problem Description
It was reported that the patient had an implant failure and subsidence of cervical grafts.The screws on the cervical plate backed out of the supposedly locked.The device was removed and replaced with non-stryker cervical plate.

• Brand Name: REFLEX-HYBRID 2 LEVEL ACP SIZE 34MM
• 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: 5419792
• Report Number: 0009617544-2016-00052
• Device Sequence Number: 18993963
• Product Code: KWQ
• UDI-Device Identifier: 04546540534828
• UDI-Public: 04546540534828
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Followup
• Report Date (Section B): 01/15/2016

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: 48651234
• Device Lot Number: 094757
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2016
• Supplement Report FDA Received Date: 04/11/2016
• 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: 57 YR
• Patient Weight: 91