MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG MULTI-AXIAL SCREW FOR 4.75MM ROD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 54740005530

Device Problem Break (1069)

Patient Problems Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): no.For similar product marketed in us is k091974.Product is not returned at the time of this report.Analysis report will be attached to supplemental report once product is received back and analysed.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of th12 vertebral body fracture.It was predicted that the fusion had not achieved after plf (revision surgery) which was performed on (b)(6) 2019 and screw breakage had occurred.The patient had recovered for a while, but symptom relapses and the patient has become difficult to walk now.For the paralysis due to the kyphosis after surgery performed at th12 and posterior movement of the bone fragment, posterior decompression and instrumentation and bone graft had been performed, but one screw on the left side of l1 broke, the fixing force was lost.There were fragments left in the patient.Health damage in patient is reported.After the operation, the screw broke.The re-operation was performed on (b)(6), 2020 (imp of non-medtronic was placed from anterior side).It has not decided to replace the screw that used for posterior spinal fusion, so the screw was not planned to be returned.The re-operation was completed on (b)(6) by posterior instrumentation from th8 to l1 and iliac bone graft on th10/11/12 of the pseudo joint.The broken screw was removed without leaving any fragment in the patient's body, and all other screws were replaced because they were found to be loose.

• Brand Name: MULTI-AXIAL SCREW FOR 4.75MM ROD
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 10300879
• MDR Text Key: 199713679
• Report Number: 1030489-2020-00941
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54740005530
• Device Catalogue Number: 54740005530
• Device Lot Number: H5517992
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2019
• 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 Weight: 47