MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS QUINTEX DYNAMIC SCREW 4.0X14MM; MPLANTS CERVICAL STABILISATIO

Model Number SC602T

Device Problem Device Issue (2379)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).It was reported that there were three patients were the screw loosened.It was reported that there was no harm to one patient.One patient had revision surgery since there was a screw located near the esophagus.Components in use listed as concomitant devices are: sc602t / quintex dynamic screw 4.0x14mm; sc623t / quintex dynamic plate 2-level 40mm.

Manufacturer Narrative

Investigation: no product at hand.Batch history review: the manufacturing documents of both lots have been checked and found to be according to specification valid during the time of production.Conclusion and root cause: the root cause for this problem is most probably usage related.Rational: we have neither the implants nor the insertion instrument.Therefore a root cause analysis is not possible.We assume that the screw was not properly inserted/tightened.No capa is necessary.

• Brand Name: QUINTEX DYNAMIC SCREW 4.0X14MM
• Type of Device: MPLANTS CERVICAL STABILISATIO
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; 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: 6447398
• MDR Text Key: 71325690
• Report Number: 9610612-2017-00188
• 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: Initial,Followup
• Report Date: 10/16/2017

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: SC602T
• Device Catalogue Number: SC602T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/24/2017
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: 09/14/2016
• Supplement Dates FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SC602T / QUINTEX DYNAMIC SCREW 4.0X14MM; SC623T / QUINTEX DYNAMIC 2-LEVEL 40MM
• Patient Outcome(s): Other