MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482802740
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; upon final tightening of screws, the surgeon noticed that one of the blockers was recessed further into the head of the screw than the other 3 screws in the procedure.After both ap and lateral x-rays were performed, it was realized that the head of the screw had become dislocated from the shaft of the screw and separated.The screw was removed and replaced with a rescue screw.Upon final tightening with the rescue screw, the other screw on the same side also became dislocated.Again, this screw was also replaced with a rescue screw.Both screws were saved for further evaluation.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed and no anomalies were found.Conclusion: the cause of the reported product issue cannot be determined based on the information provided.
Event or Problem Description
It was reported that; upon final tightening of screws, the surgeon noticed that one of the blockers was recessed further into the head of the screw than the other 3 screws in the procedure.After both ap and lateral x-rays were performed, it was realized that the head of the screw had become dislocated from the shaft of the screw and separated.The screw was removed and replaced with a rescue screw.Upon final tightening with the rescue screw, the other screw on the same side also became dislocated.Again, this screw was also replaced with a rescue screw.Both screws were saved for further evaluation.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5516150
• Report Number: 0009617544-2016-00128
• Device Sequence Number: 394113
• Product Code: MNH
• UDI-Device Identifier: 07613327002003
• UDI-Public: (01)07613327002003
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 482802740
• Device Lot Number: 138938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2016
• Supplement Report FDA Received Date: 05/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR