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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN RODS

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MEDOS INTERNATIONAL SàRL CH UNKNOWN RODS Back to Search Results
Catalog Number UNK RODS
Device Problem Break (1069)
Patient Problems Spinal Column Injury (2081); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
On (b)(6) 2014, the surgery for asd was performed by using the expedium system. The fixed area was t9 ¿ sai. Since it was found that the two rods (at left l4/5 and at right l5/s) had been broken, the reoperation for rod reinforcement was performed on (b)(6) 2017. Four universal connectors were used at one level above and below the broken site of the rods. ((b)(4) is related to (b)(4)).
 
Manufacturer Narrative
Product complaint # (b)(4). One (1) unknown section of the rod (prod code: unknown, lot # unknown) was returned to the complaints handling unit (chu) for evaluation. Only 6 cm of the rod returned. Visual examination of the section of rod returned does not appear to have broken on either side. A review of the device history record was could not be performed as the portion of rod returned did not display the lot number. All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting. Visual examination of the section of rod returned does not appear to have broken on either side. The investigation could not verify or identify any evidence of product contribution to the reported problem. It is not suspected that the product failed to meet specifications. Therefore, no further investigation is required at this time. As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameUNKNOWN RODS
Type of DeviceUNKNOWN
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
SZ
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7382818
MDR Text Key103914531
Report Number1526439-2018-50278
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK RODS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/29/2018 Patient Sequence Number: 1
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