MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN MONO/POLYAXIAL SCREWS

Device Problem Unstable (1667)

Patient Problems Tissue Damage (2104); Blood Loss (2597); Not Applicable (3189)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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 the pedicle screw of l4 left couldn't stabilize the rod.

Manufacturer Narrative

(b)(4).The unknown mono/poly screws returned to the complaint handling unit (chu).A number of pedicle screws and rods were returned.The unknown pedicle screws(s) could not be confirmed to be the returned parts.There were no visual defects to these parts beyond minor surface wear associated with signs of use.The tulip heads of the screws had the proper range of motion and there were no difficulties in moving the tulip heads.There were no issues found in the use of these products.The lot numbers could not be confirmed.Without the lot numbers, no review of their manufacturing records could be completed.No root cause analysis is necessary at this time as no product failures have been identified during the course of this investigation.No issues could be identified in the manufacturing or release of this product.Additionally, no product failures have been identified in this complaint file.Therefore, 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.

• Brand Name: UNKNOWN MONO/POLYAXIAL SCREWS
• Type of Device: UNKNOWN
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL 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 Key: 7837377
• MDR Text Key: 118912279
• Report Number: 1526439-2018-50821
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 75