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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNK - PROBES: EXPEDIUM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH UNK - PROBES: EXPEDIUM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/17/2021
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - probes: expedium/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. Device evaluated by mfr: 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 that on (b)(6) 2021, during laminectomy with spinal fusion surgery during palpation of the right l5 pedicle, the ball point probe broke and could not be safely removed. The surgeon believed that the risk of morbidity with attempted removal, out weighted any benefit. The broken portion ( approximately 2. 5cms) was left inside the patient and disclosed to the patient. Further imaging indicates that the small metallic portion in the bone has not moved. There was a minimal surgical delay. This report is for one (1) unk - probes: expedium. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameUNK - PROBES: EXPEDIUM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
CMW MFG & MATERIAL WAREHOUSE
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12882326
MDR Text Key281326436
Report Number1526439-2021-02477
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 Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unkown

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