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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH IEXP TI FIXED BLT 6 X 45MM UNKNOWN

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MEDOS INTERNATIONAL SàRL CH IEXP TI FIXED BLT 6 X 45MM UNKNOWN Back to Search Results
Catalog Number 175422645
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Spinal Column Injury (2081); Depression (2361); Not Applicable (3189)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative

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

During the post op control the surgeon and the patient have seen on xrays that one of the lower offset connector has moved and was no more in the original position. The patient also wrote a complaint letter on it. This letter and the x-ray can be found enclosed. Procedure: lumbar fixation + plif.

 
Manufacturer Narrative

Product complaint # (b)(4). Visual examination of the returned device did not show any signs of damage. Light tool markings showed that it had seen some use. The returned image showed that the bolt and its associated parts had shifted postoperatively, moving away from the rod that it was supposed to be attached to. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting. The root cause of the connector shifting postoperatively cannot be determined from the sample and the information provided. A potential root cause may be the set screw associated with the bolt/connector assembly loosening from the top of the rod postoperatively, potentially allowing the bolt to migrate. 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.

 
Manufacturer Narrative

Device received. Investigation will be conducted.

 
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Brand NameIEXP TI FIXED BLT 6 X 45MM
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 Key7442948
MDR Text Key105907692
Report Number1526439-2018-50383
Device Sequence Number1
Product Code NKB
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,Followup
Report Date 03/23/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number175422645
Device LOT NumberTBRGL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/24/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/15/2017
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: 04/19/2018 Patient Sequence Number: 1
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