MAUDE Adverse Event Report: DEPUY SYNTHES SPINE ACC5.5 SS SI POLYSCR 6.0 X 65; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	188112665
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	11/10/2017
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
The head of the screw had broken off right at the neck of the screw.The patient was returning for revision of these broken screws at s1 bilaterally.

• Brand Name: ACC5.5 SS SI POLYSCR 6.0 X 65
• 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: 7074526
• Report Number: 1526439-2017-50032
• Device Sequence Number: 1357776
• Product Code: NKB
• UDI-Device Identifier: 10705034146850
• UDI-Public: 10705034146850
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041119
• 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
• Report Date (Section B): 11/07/2017

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: 188112665
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR