MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This report is against user facility medwatch number mw5090961.The only information contained in this report is correction or additional information.The following was initially reported on report: this report is for an unknown spine screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Initial report of event was reported from patient under fda complaint form mw5090961: it was reported that on (b)(6) 2014, the patient broke their back from a fall and was implanted with a titanium rod, six (6) screws, and two (2) squirrel cages.The patient experienced pain, rash, hives, and itching at surgery site immediately post-operatively.The symptoms continued to worsen and the patient started having anaphylaxis episodes requiring allergic reaction treatment.Allergy tests completed confirmed the patient was highly 3++ allergic to titanium, nickel, cobalt, and magnesium.Hardware revision surgery occurred on (b)(6) 2019 and the rod was removed.The patient continues to have allergic reactions post revision surgery.This is report 6 of 10 for (b)(4).This report is for an unknown screw.

• Brand Name: UNKNOWN SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9553287
• MDR Text Key: 189351061
• Report Number: 1526439-2020-00167
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1