MAUDE Adverse Event Report: DEPUY SPINE INC ANTI BACKOUT SCREW, 25 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	172803025
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	01/29/2019
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 doctor performed a l5-s1 alif surgery with syncage evolution and bowti on (b)(6) 2019.Surgery was completed with no complications or delays.Doctor took at the start of stage 2 of the surgery (b)(6) 2019 and noticed that the bowti and syncage backed out from original placement on day one of surgery.Doctor is ordering a ct scan this evening.Based off the ct scan he is going to determine if the patient will need to be brought back to surgery tomorrow.I was not present or involved in stage two of surgery (b)(6) 2019.Did the patient experience a post-op device malfunction? yes.If yes, please describe.Implants moved anterior.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown.Did the patient require revision surgery or hardware removal? unknown.If no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? ct scan.Patient status/ outcome / consequences: unknown.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? unknown at this time.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required? yes.If yes, describe: ct scan ordered.Is the patient part of a clinical study? unknown.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Surgical intervention.

• Brand Name: ANTI BACKOUT SCREW, 25 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8363380
• Report Number: 1526439-2019-51380
• Device Sequence Number: 1923904
• Product Code: KWQ
• UDI-Device Identifier: 10705034015675
• UDI-Public: (01)10705034015675
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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: 172803025
• Device Catalogue Number: 172803025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 02/28/2019
• 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
• Patient Age: 71 YR