MAUDE Adverse Event Report: DEPUY SPINE INC AEGIS SCREW, 24MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	187155024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
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
L5-s1 alif: (b)(6) hospital, (b)(6) 2019.Patient came in to get posterior stabilization (dos (b)(6) 2019) after having an alif in 2015.Patient had a small spondi (slippage of l5 over s1).The slippage broke the two lower screws rather than pulled them out.Patient outcome: surgeon determined the implants are of no danger or import given they were getting stabilized in the back as well.Plate was still intact and both l5 screws were holding strong.No screw backouts.Patient age: (b)(6), dob: (b)(6).This complaint involves two (2) devices.

• Brand Name: AEGIS SCREW, 24MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8874164
• Report Number: 1526439-2019-51951
• Device Sequence Number: 14050829
• Product Code: KWQ
• UDI-Device Identifier: 10705034136332
• UDI-Public: (01)10705034136332
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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: 187155024
• Device Catalogue Number: 187155024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/08/2019
• 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: 34 YR