MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS CANNULATED SCREW DIA 4.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.

Model Number	48285440
Health Effect - Clinical Codes	Pain (1994); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be provided upon receipt of additional information.
Event or Problem Description
It is reported that during a helical removal of the screw, the screw head got blocked laterally, causing potential consequences on the muscle tissue.The screw was removed without adverse consequences for the patient, and no delay.Per email correspondence, the removal surgery was due to medical decision due to pain.There is no indication of product related issue which resulted in the reported pain or the revision surgery.
Event or Problem Description
It is reported that during a helical removal of the screw, the screw head got blocked laterally, causing potential consequences on the muscle tissue.The screw was removed without adverse consequences for the patient, and no delay.Per email correspondence, the removal surgery was due to medical decision due to pain.There is no indication of product related issue which resulted in the reported pain or the revision surgery.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, risk assessment result: visual inspection was performed and it was found that the tulip threading is damaged and tulip head is overextended on the screw shank, causing it to be jammed and loose poly-axiality.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Due to lack of information received, the root cause of the reported event could not be determined conclusively but potentially could be because of one or more of the following factors: cross-threading of screwdriver with the screw during removal.Previously deformed/ damaged removal device was used.Excessive angulation of screw or instrument, causing cantilever loading.Incorrect removal tools used.

• Brand Name: MANTIS CANNULATED SCREW DIA 4.5X40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7285967
• Report Number: 0009617544-2018-00050
• Device Sequence Number: 1741886
• Product Code: MNH
• UDI-Device Identifier: 04546540567239
• UDI-Public: (01)04546540567239
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K073151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 48285440
• Device Catalogue Number: 48285440
• Device Lot Number: 14H392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1