MAUDE Adverse Event Report: STRYKER SPINE-US ESCALATE EXPANDABLE PLATE; SPINAL INTERLAMINAL FIXATION ORTHOSI

Model Number	48570300
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, a plate was over expanded and came apart.The plate was taken out and replaced.There was a reported delay of 4/5 minutes.The procedure was completed successfully and there are no reports of adverse consequences.
Event or Problem Description
It was reported that during a procedure, a plate was over expanded and came apart.The plate was taken out and replaced.There was a reported delay of 4/5 minutes.The procedure was completed successfully and there are no reports of adverse consequences.
Additional Manufacturer Narrative
Method: visual inspection, functional inspection, device history review, complaint history review, risk assessment.Result: the reported event of plate fracture was not confirmed.The plate was able to be reassembled without issue, no visual anomalies were identified on a plate.Manufacturing records for this product were reviewed and no anomalies were found.Conclusion: the failure mode was not confirmed as no issue was identified with the returned plate.It was reported that the plate was over expanded and came apart.This may have been caused by user applying too much force on instrument or implant incorrectly aligned with instrument, causing additional stress.

• Brand Name: ESCALATE EXPANDABLE PLATE
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSI
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7244905
• Report Number: 0009617544-2018-00034
• Device Sequence Number: 19091569
• 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): 05/24/2018

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: 48570300
• Device Catalogue Number: 48570300
• Device Lot Number: 16A617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1