MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ESCALATE EXPANDABLE PLATE; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Model Number	48570300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plate pulled apart when expanding it.Pulled plate out and new plate was used.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: no relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: the root cause is undetermined and is multifactoral.
Event or Problem Description
It was reported that the plate pulled apart when expanding it.Pulled plate out and new plate was used.

• Brand Name: ESCALATE EXPANDABLE PLATE
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6567967
• Report Number: 0009617544-2017-00203
• Device Sequence Number: 13479165
• Product Code: NQW
• UDI-Device Identifier: 07613252464228
• UDI-Public: (01)07613252464228
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K113802
• 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): 08/24/2017

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 Model Number: 48570300
• Device Catalogue Number: 48570300
• Device Lot Number: 167503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 04/20/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1