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

Catalog Number	55840009590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 posterior spinal fusion (psf) form t10 to s2 due to degenerative scoliosis.Post-op, the implanted screw was broken and broken parts are still in the patient.No patient symptoms or complication were reported as result of this event.Patient did not undergo any removal surgery yet.
Additional Manufacturer Narrative
Additional information: x-ray review- a single lateral x-ray was provided for a thoracic pelvic fixation.By report one of the screws was broken.The provided image shows nearly 18 screws.If information is provided in the future, a supplemental report will be issued.

• 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: 8554214
• Report Number: 1030489-2019-00478
• Device Sequence Number: 11327714
• Product Code: KWP
• UDI-Device Identifier: 00643169005327
• UDI-Public: 00643169005327
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 55840009590
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1