MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS LONG CONSTRUCT HEX RAD ROD 6.0 X 90MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.

Model Number	48486090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Supplemental report will be submitted upon investigation completion.
Event or Problem Description
It was reported that when the rod was inserted with a rod inserter for lumbar spondylolisthesis, the rod was broken at around rod holder.However, the rod was fixed with blocker and the operation was finished.No adverse consequences to the patient is reported.
Event or Problem Description
It was reported that when the rod was inserted with a rod inserter for lumbar spondylolisthesis, the rod was broken at around rod holder.However, the rod was fixed with blocker and the operation was finished.No adverse consequences to the patient is reported.
Additional Manufacturer Narrative
Method: visual inspection, material analysis, device history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via visual inspection.Rod was confirmed to be broken at the hex end.Material analysis concluded: the rod end fractured in a bending ductile overload mode.The elemental composition matched what was specified on the print.No material or manufacturing defects were found.Manufacturing history was reviewed and no issues were identified.Conclusion: per information provided, the rod was impacted and the angle at which it was inserted was too steep.The most probable root cause of the reported event was determined to be impaction and steep angle at which the rod was inserted that led to its fracture.

• Brand Name: MANTIS LONG CONSTRUCT HEX RAD ROD 6.0 X 90MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7284859
• Report Number: 0009617544-2018-00048
• Device Sequence Number: 1368095
• Product Code: MNH
• UDI-Device Identifier: 04546540671554
• UDI-Public: (01)04546540671554
• Combination Product (Y/N): N
• PMA/510(K) Number: K092631
• 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: 48486090
• Device Catalogue Number: 48486090
• Device Lot Number: SL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 02/20/2018
• 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
• Patient Age: 69 YR
• Patient Weight: 56