MAUDE Adverse Event Report: DEPUY SPINE INC EXP 4.5 TI SINGLE INNIE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186100001
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/10/2018
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 that dr.(b)(6) did the primary fusion on october 1st.This fusion involved expedium 4.5 in combination with the special access system trolley.Dr.(b)(6) mentioned that he overcorrected the scoliosis and there was a proximal pullout of the construct.Basically the first set screw on the left side of the construct at t3 completely came off and consequently the screw at t4 completely pulled out of the pedicle as there was tremendous stress on that screw.This particular screw was replaced with a new 4.35x30mm and a new rod and new set screw was place on the first screw.The patient was affected by this revision, info is below.No replacement is needed.I have nothing further to add.Patient consequence? yes.Patient consequence description:the patient needed revision surgery in order to correct the pop off cap and pullout screw.Action taken for procedure: revision surgery.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

• Brand Name: EXP 4.5 TI SINGLE INNIE
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8212469
• Report Number: 1526439-2019-51190
• Device Sequence Number: 16804320
• Product Code: NKB
• UDI-Device Identifier: 10705034103846
• UDI-Public: (01)10705034103846
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2018

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: 186100001
• Device Catalogue Number: 186100001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Weight: 27