MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 HEX STRAIGHT ROD 5.5 X 480MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482807480
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2016, a surgery for th12 burst fracture was performed.First, the screws were inserted to th 9-11/l1-3 and the vertebroplasty of t12 was performed.A rod broke at the hex end when the surgeon tried to insert the rod to right side.The surgeon removed the broken rod from the patient and reinserted the rod with a rod rotation forceps.After that, the surgery was completed without problems.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: materials analysis revealed that the rod was found to have fractured in a ductile bending overload due to and applied normal stress.The elemental composition was consistent with what is specified on the print.No material or manufacturing defects were found.Conclusion: the cause of the reported product issue cannot be determined based on the information provided.
Event or Problem Description
It was reported that on (b)(6) 2016, a surgery for th12 burst fracture was performed.First, the screws were inserted to th 9-11/l1-3 and the vertebroplasty of t12 was performed.A rod broke at the hex end when the surgeon tried to insert the rod to right side.The surgeon removed the broken rod from the patient and reinserted the rod with a rod rotation forceps.After that, the surgery was completed without problems.

• Brand Name: ES2 HEX STRAIGHT ROD 5.5 X 480MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5484957
• Report Number: 0009617544-2016-00099
• Device Sequence Number: 332021
• Product Code: NKB
• UDI-Device Identifier: 07613327001709
• UDI-Public: 07613327001709
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2016

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: 482807480
• Device Lot Number: KFG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2016
• Supplement Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 75