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	Injury (2348); No Code Available (3191)
Date of Event	03/24/2017
Type of Reportable Event	Serious Injury
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.
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 (s1 right).Unk date, it was confirmed 3 screw were broken(l4 left,l5 right,s1 right).On (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: 6501557
• Report Number: 0009617544-2017-00154
• Device Sequence Number: 531028
• 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): 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 482802645
• Device Lot Number: 14D554
• 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: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention