MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48644014
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw damaged during the surgery.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: materials analysis was performed and no material or manufacturing defects were found.The stryker rep was able to confirm the patient's hard bone quality due to her condition conclusion: a plausible root cause is patient¿s hard bone.
Event or Problem Description
It was reported that the screw damaged during the surgery.

• Brand Name: REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW
• 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: 5429024
• Report Number: 0009617544-2016-00053
• Device Sequence Number: 18902617
• Product Code: KWQ
• UDI-Device Identifier: 04546540534682
• UDI-Public: 04546540534682
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K040261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2016

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: 48644014
• Device Lot Number: M2F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2016
• Supplement Report FDA Received Date: 05/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1