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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNK - SCREWS: PEDICLE ORTHOSIS, SPINAL PEDICLE FIXATION

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MEDOS INTERNATIONAL SàRL CH UNK - SCREWS: PEDICLE ORTHOSIS, SPINAL PEDICLE FIXATION Back to Search Results
Device Problem Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. If the information is unknown, not available or does not apply, the section/field of the form is left blank. H10 additional narrative: this report is for an unk - screws: pedicle/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. (b)(4). Device evaluation by mfr and manufacture date: 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.
 
Event Description
It was reported on an unknown date that the surgeon operated on a patient about 7 weeks ago, it was a revision/extension of a previous lumbar fusion and he used our expedium screw and instrument system. The patient was complaining of some mild back pain and after reviewing some post-op x-rays, surgeon discovered that apparently about 3 of the set screws at the proximal end of the construct had popped off of the pedicle screws and now the rods were lifting up and out of the polyaxial head of the screw. Surgeon does not plan to re-operate to address this but he will be monitoring the patient's symptoms closely and may have to schedule another surgery to stabilize the construct. This report is for one (1) unk - screws: pedicle this is report 2 of 3 for complaint (b)(4).
 
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Brand NameUNK - SCREWS: PEDICLE
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle
Manufacturer Contact
kate karberg
chemin-blanc 38
le locle 
SZ  
3035526892
MDR Report Key15204308
MDR Text Key297672164
Report Number1526439-2022-01388
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/10/2022 Patient Sequence Number: 1
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