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

Catalog Number	482802745
Medical Device Problem Codes	Mechanical Problem (1384); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	10/20/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2016, the patient underwent the surgery.On (b)(6) 2016, the surgeon confirmed x-ray.And he found that the screw of t12 and l1 backed out.Therefore, the surgeon planning the revision surgery on (b)(6) 2016.After surgery, the patient was not used the corset.
Additional Manufacturer Narrative
Complaint history review; device history review; risk assessment.Review of manufacturing records revealed no manufacturing issues, as all products met specifications.Device was not returned.The root cause cannot be determined conclusively, as the device was not returned.
Event or Problem Description
It was reported that on (b)(6) 2016, the patient underwent the surgery.On (b)(6) 2016, the surgeon confirmed x-ray.And he found that the screw of t12 and l1 backed out.Therefore, the surgeon planning the revision surgery on (b)(6) 2016.After surgery, the patient was not used the corset.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 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: 6107537
• Report Number: 0009617544-2016-00463
• Device Sequence Number: 16320753
• Product Code: KWP
• UDI-Device Identifier: 07613327002010
• UDI-Public: (01)07613327002010
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2017

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: 482802745
• Device Lot Number: 162062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR