MAUDE Adverse Event Report: SYNTHES USA 1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM; SCREW FIXATION, INTRAOSSEOUS

Catalog Number 400.456E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient had a follow-up visit after having had two (2) surgical procedures.The first was a distractor implant procedure on (b)(6) 2015 followed by a revision procedure to implant five (5) to six (6) additional screws on (b)(6) 2015.During the follow-up visit, the surgeon noticed the development of a staphylococcal infection.The surgeon also noticed difficulty in the left side distractor turning and moving.The surgeon was planning to remove the distractor after the infection resolved.The patient was prescribed antibiotics to resolve the infection.The right side distraction had completed and reached the surgeons objectives.When the infection resolved, the distractor was removed on (b)(6) 2015.During that procedure, the surgeon found the bone to be completely healed on both sides, which is not an expected result for distraction.An osteotomy was performed on the left side and a new distractor (2.0 curvilinear straight distractor) was implanted.The surgeon was going to wait two (2) days, then begin distracting 1mm per day for 15 days (starting (b)(6) 2015).An osteotomy was performed on right side so that the unilateral distraction would allow the mandible to pivot.No distractor was needed on the right side.No additional information is available.This report is 2 of 7 for (b)(4).

Manufacturer Narrative

Patient weight is reported as (b)(6).Unknown ¿ revision procedure occurred on (b)(6) 2015.(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development evaluation was performed for the subject device (part number 400.456e, 1.3mm ti crtx screw slf-drlg w/plusdrive(tm) recess 6mm, lot number unknown).The subject device was returned showing signs implantation.The returned screw was returned undamaged and intact.The associated drawings for the subject device were reviewed and no drawing issues or discrepancies were noted.The design is determined to be suitable for the intended use when employed and maintained as recommended and it did not contribute to the complaint condition.Proper use and maintenance for the device is addressed in technique guide.The complaint condition could not be replicated, and the cause of the complaint condition could not be determined from the supplied information.This complaint is unconfirmed.The exact cause of the complaint condition could not be determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device has been received and is currently in the evaluation process.The actual date of implant may have been (b)(6) 2015.It is unknown which of the reported screws where implanted on which of the reported dates.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received on september 1, 2015: it was reported that the patient underwent a revision surgery on (b)(6) 2015.During the revision surgery, the surgeon found the bone completely healed on both sides, which is not an expected result for distraction.An osteotomy was performed on the left side and a new distractor (2.0 curvilinear straight distractor) was implanted.The surgeon is going to wait two days then begin distracting 1mm per day for 15 days (starting (b)(6) 2015).An osteotomy was performed on right side so that the unilateral distraction would allow the mandible to pivot.A distractor was not needed on the right side.No additional information is available.Initially, the patient underwent the implantation of two distractors and associated hardware on (b)(6) 2015 and the subsequent implantation of 6 additional screws on (b)(6) 2015 due to plate loosening.The details of this first revision surgery are addressed and were reported under the related complaint, (b)(4).During the follow-up visit the surgeon noticed the development of a staphylococcal infection.The surgeon also noticed difficulty with the left side distractor turning and moving.The patient underwent antibiotic treatment and the surgeon planned to remove the distractor after the infection was resolved.The right side distraction was completed and has reached treatment objectives.During the follow-up visit the surgeon noticed the development of a staphylococcal infection.The surgeon also noticed difficulty with the left side distractor turning and moving.The patient underwent antibiotic treatment and the surgeon planned to remove the distractor after the infection was resolved.The occurrence of infection was addressed under related complaint (b)(4).This complaint addresses the details of the revision surgery performed on (b)(6) 2015, the patient condition and planned treatment.This report is 2 of 21 for (b)(4).

• Brand Name: 1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM
• Type of Device: SCREW FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4771007
• MDR Text Key: 5951950
• Report Number: 2520274-2015-13839
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK983485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400.456E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention