MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE L 7.5X45MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	482804745
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when reduction with the reduction thread at the lumbar spondylolisthesis at l4 part, the blade screw was broken.Although the surgeon was tried to use the recovery system, it was not se with screw.Thereore, the screw was changed the new one and the operation was succeeded.The blade was not resisted the force of the reduction, because the bone quality was good and the screw fixation was good.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.The customer reported event was confirmed.The returned device was fractured in 3 pieces.Manufacturing history was reviewed and no issues were identified.The exact root cause could not be determined conclusively.However it is likely that the screw tab may have fractured due to excessive stress applied on the construct while inserting the blockers.
Event or Problem Description
It was reported that; when reduction with the reduction thread at the lumbar spondylolisthesis at l4 part, the blade screw was broken.Although the surgeon was tried to use the recovery system, it was not se with screw.Therefore, the screw was changed the new one and the operation was succeeded.The blade was not resisted the force of the reduction, because the bone quality was good and the screw fixation was good.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X45MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6838768
• Report Number: 0009617544-2017-00346
• Device Sequence Number: 13810640
• Product Code: KWP
• UDI-Device Identifier: 07613327002232
• UDI-Public: (01)07613327002232
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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 Model Number: 482804745
• Device Catalogue Number: 482804745
• Device Lot Number: 168719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR