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

Catalog Number	7576545
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 presented with spondylolisthesis; and underwent transforaminal lumbar interbody fusion (tlif) and minimally invasive percutaneous pedicle screw fixation (mis-ppf) at one level.After one day, post-op, the implanted screw broke.The head of the screw got separated from the body.The patient also reported back pain.Hence, the patient underwent a revision surgery, in which all the implants were completely explanted; and were replaced with products manufactured by another manufacturer.The patient is recovering after the revision surgery.No other issues were reported.
Additional Manufacturer Narrative
X-ray review results: post-op x-rays for l4-l5 tlif were provided.A grade 1-2 spondylolisthesis is observed that does not appear corrected.An interbody graft is present, there is a paucity of bone in the interbody space.One of the l4 screws appears fractured at the tulip/screw junction.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: 9666623
• Report Number: 1030489-2020-00133
• Device Sequence Number: 2756640
• Product Code: KWP
• UDI-Device Identifier: 00885074031156
• UDI-Public: 00885074031156
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2020

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: 7576545
• Device Lot Number: Z99
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 04/11/2020
• 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: 60 YR