MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXP 635 TI SI SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	179902000
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
(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
It was reported via voicemail, there was an issue with 2 set screws, 1799-02-000.Additional information from submitted complaint form from sales rep.Patient noticed a change in feeling in his back.Upon, x-ray, it was noticed that the set screws in the iliac bolts an s1 screws had loosened and came off.

• Brand Name: EXP 635 TI SI SETSCREW
• 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: 7179294
• Report Number: 1526439-2018-50033
• Device Sequence Number: 11075033
• Product Code: NKB
• UDI-Device Identifier: 10705034084664
• UDI-Public: 10705034084664
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• 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): 12/15/2017

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: 179902000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/10/2018
• 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