MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN

Model Number MSB_UNK_SCREW

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Pma / 510k # is unknown since product identifier details are unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via the manufacturer representative of an event occurred during an posterior arthrodesis with pelvis fixation (levels implanted: t3-s1) in the pediatric surgery block in a patient diagnosed with neurologic scoliosis.It was reported that patient had an x-ray after the original procedure and found that the second screw (which was implanted) has also been disconnected due to threading issue and the patient underwent a revision surgery in october.The product in question has had contact with the patient.The screw was placed but was removed following the issue with the threading.No patient complications reported.

• Brand Name: UNKNOWN
• 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: 10990438
• MDR Text Key: 220890370
• Report Number: 1030489-2020-01776
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention