MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS QUINTEX SEMICONSTRAINED SCREW 4.0X16MM; BONE SCREW

Model Number SC503T

Device Problems Disassembly (1168); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Loosening / disassembly of quintex screw rings.

Manufacturer Narrative

Product was not returned for evaluation.Based on the available information it is not possible to make an assumuption about the cause as to why the rings fell out of the screws.The most likely root cause of the failure is design.Capa has been initiated at the (b)(4).

• Brand Name: QUINTEX SEMICONSTRAINED SCREW 4.0X16MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5112495
• MDR Text Key: 27150463
• Report Number: 3005673311-2015-00146
• 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
• Type of Report: Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SC503T
• Device Catalogue Number: SC503T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other