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

Model Number	187701015
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/01/2017
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.
Event or Problem Description
On march 26, 2018, it was reported by the hospital that the same event as the following three complaints had occurred in 2017.(b)(4).This is the 4th same event in which the expedium set screws (part#: unk) fixed at the caudal end had been loosened thus the corrective force was lost.For details, please refer to the above three complaints.No further information has been provided by the hospital.

• Brand Name: EXP ANT SET SCREW
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7444114
• Report Number: 1526439-2018-50391
• Device Sequence Number: 1963547
• Product Code: KWQ
• UDI-Device Identifier: 10705034138336
• UDI-Public: (01)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): 03/26/2018

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 Model Number: 187701015
• Device Catalogue Number: 187701015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/19/2018
• 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