MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SI POLYAXL SCREW 7 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	179712745
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hematoma (1884); Not Applicable (3189)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
"spinal stenosis of the lumbar spine with claudicatiospinalis symptoms, two-sided foot weakness and knee extensors palsy left.These issues should be handled and repaired a spinal fusion operation.A ventral interpositions spinal fusion at l5/s1 was carried out for this purpose.A defective pedicle screw was used during the operation (l4), which caused a hemorrhage and nerve compression.The revision surgery of the (b)(6) 2017 the pedicle screw in l4 removed, because it showed a fissure of the pedicle.Hematoma at l4 and l5 (right) have been addressed.The screw in l3 (right) has been through a 5 mm longer bolt replaced.

• Brand Name: SI POLYAXL SCREW 7 X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7174685
• Report Number: 1526439-2018-50016
• Device Sequence Number: 19320734
• Product Code: NKB
• UDI-Device Identifier: 10705034067902
• UDI-Public: 10705034067902
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 179712745
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention