MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 55740006540

Device Problem Malposition of Device (2616)

Patient Problem Disability (2371)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from hcp via manufacturing representative regarding patient with unknown indication for spinal therapy.Type of procedure used: removal of bone fragments, screw reinsertion.Levels implanted: implanted level was l4/5.Patient outcome: health damage in the patient was reported.There was a delay in overall procedure less than 60 min.Patient symptoms were drooping foot/disability.It was reported that screw on the right side of l5 was out of bound.It was suspected that the nerves were stimulated by the bone fragments which caused by the pedicle fracture attributed to the ob (out of bound) of the screw on the right side of l5, so symptom occurred on the unaffected side.Device status: explant complete.Return status: unknown no further complications reported.Update 17-jul-2020; the waveform of intraoperative monitoring seems to have recovered a little, but the patient became unable to lift his ankle and decided to put on the brace.Product status: customer discarded.

• Brand Name: MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10306417
• MDR Text Key: 199866267
• Report Number: 1030489-2020-00945
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2020

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
• Device Operator: Health Professional
• Device Model Number: 55740006540
• Device Catalogue Number: 55740006540
• Device Lot Number: H5452833
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/22/2020
• Date Device Manufactured: 07/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 65 YR
• Patient Weight: 54