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

Catalog Number 48651234

Device Problems Mechanical Problem (1384); Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 01/15/2016

Event Type  Injury  

Event 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.

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 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
• 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 NJ 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5419792
• MDR Text Key: 37786350
• Report Number: 0009617544-2016-00052
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 04546540534828
• UDI-Public: 04546540534828
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48651234
• Device Lot Number: 094757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2009
• 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: 57 YR
• Patient Weight: 91