MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREWS: EXPEDIUM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - screws: expedium/ unknown lot.Part and lot numbers are unknown; udi number is unknown.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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images.The images were reviewed, and the complaint condition is confirmed.The expedium screw appears to have post-operatively broken into two pieces at the head.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.No lot number was provided or found in the photos, therefore no dhr could be performed.If a valid lot number is provided or the physical device returned, the dhr will be revisited.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: no lot number was provided or found in the photos, therefore no dhr could be performed.If a valid lot number is provided or the physical device returned, the dhr will be revisited.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient was treated with expedium screws back on (b)(6) 2018.Patient was presented to the clinic on (b)(6) 2021.After further investigation, x-ray showed broken expedium screw.Its only one broken screw, the case was a two-level lumber fusion.So out of 6 screws used in the case.Only 1 was broken.The screw is not removed.It is still implanted.Until now the patient is asymptotic and thus there is no plan to intervene surgically.No further information is available.Concomitant device reported.Unknown rod (part # unknown, lot # unknown, qty 2), unknown set screw (part # unknown, lot # unknown, qty 6).This complaint involves one (1) device.This report is for (1) unk - screws: expedium.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - SCREWS: EXPEDIUM
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12875249
• MDR Text Key: 281515585
• Report Number: 1526439-2021-02476
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: TC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2021
• 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
• Treatment: UNK - LOCKING/ SET SCREWS: EXPEDIUM; UNK - RODS: EXPEDIUM; UNKNOWN SCREWS