MAUDE Adverse Event Report: STRYKER SPINE-FRANCE 31MM 1 LEVEL PLATE SACRAL; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number	49171131
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that screw would not go below the locking mechanism.New plate was chosen and screw went in fine.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the device was inspected and the locking plate was found to be deformed.No relevant manufacturing issues were identified as all units met specifications.Conclusion: the most likely root cause is improper screw alignment.
Event or Problem Description
It was reported that screw would not go below the locking mechanism.New plate was chosen and screw went in fine.

• Brand Name: 31MM 1 LEVEL PLATE SACRAL
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6554088
• Report Number: 0009617544-2017-00194
• Device Sequence Number: 10937418
• Product Code: KWQ
• UDI-Device Identifier: 07613327066388
• UDI-Public: (01)07613327066388
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• 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: 49171131
• Device Catalogue Number: 49171131
• Device Lot Number: 153862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/09/2017
• 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
• Patient Age: 68 YR