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

Model Number	179702745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
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 returned for evaluation.
Event or Problem Description
Non union at l3/broken screw - anterior scoliosis psf.Congenital scoliosis.Revision of the anterior fusion (t11-l3) of an anterior/posterior scoliosis fusion.Original surgery performed in 2007.Patient presented with a non union at l3 and a broken screw at l3.The surgeon is not sure which occurred 1st.The broken head of the screw, monoaxial screw at l2, single staple (x 1), set screws (x5) and single rod were removed.The surgeon was unable to remove the shaft of the screw at l3.Screw removed and replaced at l2 and then placed another screw, beside l2 and l3.A rod was then placed in t11-l3 and in the new screws, l2 and l3.He also placed a mesh cage in the disc space between l2 and l3 to assist with scoliosis.
Additional Manufacturer Narrative
Complaint coded in error as "broken post-op".Category changed to reflect reported event.As such, device is non-reportable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 7008983
• Report Number: 1526439-2017-10944
• Device Sequence Number: 1228600
• Product Code: NKB
• UDI-Device Identifier: 10705034065052
• UDI-Public: (01)10705034065052
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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: Physician
• Device Model Number: 179702745
• Device Catalogue Number: 179702745
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 12/01/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR