MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 2 LEVEL ACP SIZE 34MM; IMPLANT-CERVICAL PLATE

Catalog Number 48651234

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2014

Event Type  Injury  

Event Description

It was reported that reflex hybrid screws at c7 backed out with one gone from the body.

Manufacturer Narrative

Method: device history review; results: no further information was provided so the cause is unknown.Conclusion: the reflex-hybrid 2 level acp was confirmed via the stryker rep to have a screw backout requiring a revision surgery.Manufacturing records could not be reviewed because no lot number was provided.

Event Description

It was reported that reflex hybrid screws at c7 backed out with one gone from the body.

• Brand Name: REFLEX-HYBRID 2 LEVEL ACP SIZE 34MM
• Type of Device: IMPLANT-CERVICAL PLATE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: daniel roberts ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 3839571
• MDR Text Key: 4686397
• Report Number: 0009617544-2014-00243
• Device Sequence Number: 1
• Product Code: KWQ
• 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: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48651234
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2014
• 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
• Patient Age: 52 YR