MAUDE Adverse Event Report: AESCULAP AG QUINTEX CONSTRAINED SCREW 4.0X16MM; IMPLANTS CERVICAL STABILISATION

Model Number SC403T

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If additional information is received a follow up report will be submitted.Investigation: only the locking ring of the screw was received.It arrived in bent condition.A visual inspection of the locking ring was made.Here, we found that three from six spring segments are bent, two are bent inwards, and one is bent outwards.It was also noticed slight wear on the rim at upper side.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: we assume that the screw was screwed in a wrong angle.The complaint screw was screwed in fairly slanted.During screwing in a screwing in a wrong (too high) angulation, the petals become bent inwards during the contact with the edge of the hole and the ring can pop.At last, a breakage of one or more petals is possible.The ifu limits the angulation of +15 degrees/-15 degrees for medial screws in hybrid plates.The plate for this procedure was a hybrid type and the complained screw is placed in one of the medial holes.No capa necessary.

Event Description

It was reported the implant screw leaves broke intraoperatively.During a spinal surgical procedure, the surgeon was placing screw into the patient and one of the leaves of the head of the screw broke.One green leaf is missing, therefore; the locking ring was not placed in the patient.The screw remains in the patient.There was no surgical delay.No other information has been provided.Additional information has been requested, however, not yet received.

• Brand Name: QUINTEX CONSTRAINED SCREW 4.0X16MM
• Type of Device: IMPLANTS CERVICAL STABILISATION
• 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: 8476221
• MDR Text Key: 140731881
• Report Number: 9610612-2019-00192
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC403T
• Device Catalogue Number: SC403T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/14/2019
• Date Manufacturer Received: 03/05/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other