MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXP ANT SET SCREW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	187701015
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	10/25/2017
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
Account name: (b)(6) hospital.On (b)(6) 2016, surgery for scoliosis was performed using the expedium system.The fixed area was t10 ¿ l3.Recently, surgeon confirmed through an x-ray that expedium set screws (part#: unk) fixed at the caudal end were loosened, thus its corrective force was lost.Currently, re-operation is not scheduled.

• Brand Name: EXP ANT SET SCREW
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7174927
• Report Number: 1526439-2018-50019
• Device Sequence Number: 1812768
• Product Code: KWQ
• UDI-Device Identifier: 10705034138336
• UDI-Public: 10705034138336
• Combination Product (Y/N): N
• PMA/510(K) Number: K041205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2017

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: 187701015
• Device Lot Number: ATNBTC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• 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: Other