MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482802645
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	03/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2015 implanted from l4 to l5 by plif using some screws.Implanted 4 screw and l4 left, l5 right.On (b)(6) 2016, implanted to extend by peek to s from l5 by plif.Implanted 2 screws for si and fixed for l4-s by screw(s1right).Unk date, it was confirmed 3 screw were broken(l4left,l5right,s1right).On (b)(6) 2017 removed broken 3 screw and implanted new screws.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual inspection and functional inspection could not be performed.The plausible root cause of the event is could not be determined due to insufficient information and without device evaluation.
Event or Problem Description
It was reported that on (b)(6) 2015 implanted from l4 to l5 by plif using some screws.Implanted 4 screw and l4 left, l5 right.On (b)(6) 2016, implanted to extend by peek to s from l5 by plif.Implanted 2 screws for si and fixed for l4-s by screw(s1right).Unk date, it was confirmed 3 screw were broken(l4left,l5right,s1right).(b)(6) 2017 removed broken 3 screw and implanted new screws.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6501560
• Report Number: 0009617544-2017-00155
• Device Sequence Number: 1330831
• Product Code: NKB
• UDI-Device Identifier: 07613327001945
• UDI-Public: (01)07613327001945
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

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: 482802645
• Device Lot Number: 154996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1