MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS-CRANIOFACIAL; PLATE, BONE

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

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown matrixneuro construct/unknown lot.Part and lot number 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

This report is being filed after the review of the following journal article: schön s., et al (2021) 3d-printing-assisted patient-specific polymethyl methacrylate cranioplasty ¿ a case series of 16 consecutive patients, world neurosurgery , volume xxxxx, pages 1-33 (switzerland) this study aims to investigate the feasibility and safety of our entirely sterile in hospital molding procedure and pmma implant production, and to examine the goodness of the reconstruction of the skull anatomy in postoperative computed tomography (ct) scans.Between (b)(6) 2016 and (b)(6) 2018, a total of 16 consecutive patients (11 males, 5 females) who have undergone cranioplasty surgery for an extensive skull defect after decompressive surgery, and in whom the autologous bone flap was not available for reimplantation were included in the study.Implantable patient-specific ppma implant was fixed to the skull using low-profile titanium plates(depuy synthes matrixneuro, bettlach, switzerland) or craniofix system (aesculap ag, tuttlingen, germany).The median (range) follow-up period is 4.5 (0-21) months.The following complications were reported: a case of a 71 year old male (case no.1) had hygroma, without surgical relevance, and the patient was stable over the entire follow-up period without consequences.A case of a 23 year old male (case no.2) epidural hematoma, a revision surgery was necessary.A case of a 78 year old male (case no.3) had acute subdural hematoma, a revision surgery was necessary.A case of a 55 year old female (case no.5) had seizures.A case of an 89 year old male (case no.10) had epidural cerebrospinal fluid collection, which, however, was stable during the follow-up period and did not require revision surgery.A case of a 68 year old female (case no.11) had epidural hematoma, a revision surgery was necessary.A case of a 56 year old male (case no.13) had flap necrosis 6weeks following his 4th operation at the same surgical site.This report is for unknown synthes low-profile titanium plates (matrixneuro).This is report 2 of 6 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS-CRANIOFACIAL
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11358064
• MDR Text Key: 239829616
• Report Number: 8030965-2021-01203
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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: 02/01/2021
• 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