MAUDE Adverse Event Report: AESCULAP AG AND CO. KG COLUMBUS IMPLANT HOLDING/INSERTION INSTR

Model Number NQ560R

Device Problem Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Durin ga columbus surgery a screw form instrument nq560r fell off unnoticed and remained in patient.This was detected when an x-ray was taken after surgery.To date, the surgeon wants to leave the screw in the patient.

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going at (b)(4).

• Brand Name: COLUMBUS IMPLANT HOLDING/INSERTION INSTR
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG AND CO. KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3851255
• MDR Text Key: 4412147
• Report Number: 3005673311-2014-00022
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NQ560R
• Device Catalogue Number: NQ560R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1