MAUDE Adverse Event Report: AESCULAP AG QUINTEX DYNAMIC SCREW 4.0X18MM; IMPLANTS CERVICAL STABILISATIO

Model Number SC604T

Device Problems Mechanical Problem (1384); Device Damaged by Another Device (2915); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product at hand.Batch history review: because the batch number is unknown, a batch history review is not possible.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale: without further knowledge about the circumstances we assume, that the shaving was generated by screwing in the screw with a wrong angle, so that the thread scrapped the edge of the plate (screw hole).This is the basic cause in cases like that.A material defect or a manufacturing error can be excluded.

Event Description

It was reported metal shavings detaching from the screw intraoperatively.The reporter indicated the surgeon drilled and then screwed in and locked in the first two screws in c4, then drilled and screwed in the third screw in c3.This resulted in metal abrasion/ and a metal shaving sheared off from the screw (thread).The shaving was removed and the screw remained implanted.This also happened when screwing in the fourth screw.Again the shaving was removed and the screw was left implanted.Additional information has been requested, however, not yet received.Associated medwatch: 9610612-2019-00261 (third screw).

• Brand Name: QUINTEX DYNAMIC SCREW 4.0X18MM
• Type of Device: IMPLANTS CERVICAL STABILISATIO
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8525176
• MDR Text Key: 142331532
• Report Number: 9610612-2019-00281
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC604T
• Device Catalogue Number: SC604T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/08/2019
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention