MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG N/A; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	75445545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent minimal access surgical technology- posterior lumbar interbody fusion (mast- plif) at l4-5 due to lytic listhesis at that level.Post-op (during device maintenance), the screw was found broken.Reportedly, the patient was in tremendous back pain.Hence, a revision surgery was performed in which the broken screw was partially explanted, the screw shaft was left inside the patient.
Additional Manufacturer Narrative
X-ray review: post-op x-ray from l4-5 posterior lumbar fusion shows fractured l5 screw.No interbody device is present.Fusion status is unknown but failure appears to have happened in early post operative period.Hardware placement and size appears appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: N/A
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7365119
• Report Number: 1030489-2018-00445
• Device Sequence Number: 19323601
• Product Code: KWP
• UDI-Device Identifier: 00885074134024
• UDI-Public: 00885074134024
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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 Catalogue Number: 75445545
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 04/20/2018
• 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
• Patient Age: 52 YR
• Patient Weight: 75