MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179762300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device not available for evaluation.
Event or Problem Description
Revision t3-pelvis.The patient had a previous revision for broken rods in (b)(6) 2016.The patient has a history of rheumatoid arthritis.Revision (b)(6) 2017 patient has broken rods and a non union at t9.The planned operation was an anterior approach to address the non union and then turn the patient over to attend to the broken rods.Anterior operation completed and then the posterior operation.There is a very solid fusion from the previous surgery except at the non-union site.The existing rods were cut and the surgeon used connectors to add new rods and make a supportive strut construct.Xray available.

• Brand Name: EXPEDIUM
• 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: 7044900
• Report Number: 1526439-2017-11010
• Device Sequence Number: 13491821
• Product Code: NKB
• UDI-Device Identifier: 10705034077420
• UDI-Public: (01)10705034077420
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: Physician
• Device Model Number: 179762300
• Device Catalogue Number: 179762300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR