MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: CMF; SCREW, FIXATION, BONE

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

Patient Problem Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown screws: cmf/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: pereira, g.N.Et al.(2022), unicortical bone necrosis of the fibula free flap associated to the fixation with a nonlocking 2.0-mm reconstruction plate and screws, archives of plastic surgery, vol.49, no.3, pages 414 - 417 (portugal).This study presents a case report of a 42-year-old female patient with a progressive and slow-growing mass (7.5 cm x 7.5 cm x 4.5 cm) on the left side of the upper maxilla that appeared 3 years before.Intraoral examination showed a giant exophytic round-shaped lesion in the second quadrant of the mouth extending to the palate.The biopsy revealed a cof of the hard palate.Tracheostomy, excision of the tumor, left submaxilectomy, left level-2 neck dissection was performed resulting in a left hemimaxilectomy mesoinfrastructure defect classified as the cordeiro type 2b or brown class 2d.Reconstruction with a osteomusculocutaneous fibula free flap (the left leg as the donor site) using 2.0-mm-thick reconstruction plate of the matrixmandible plating system (synthes, paoli, pa) and monocortical screws (synthes).The immediate postoperative computed tomographic (ct) scan showed coaptation between the anterior segment of the fibula to the maxilla and between the anterior and posterior segment of the fibula.The postoperative course was uneventful, with no vascular complications of the flap, monitored by clinical evaluation, and in the first postoperativeweek, with the doppler monitorization of venous pedicle flow with flowcoupler.The only early complication was the development of an oronasal fistula at the posterior region of the palate that healed with conservative treatment.A copy of the literature article is being submitted with this medwatch.This report involves one unk - screws: cmf.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - SCREWS: CMF
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15528664
• MDR Text Key: 301026476
• Report Number: 8030965-2022-07711
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female