MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: MATRIX ORBITAL; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Device Problems Defective Device (2588); No Apparent Adverse Event (3189)

Patient Problems Nerve Damage (1979); Blurred Vision (2137); Non-union Bone Fracture (2369); Numbness (2415); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, patient had a psi plate placed on right cheek extending to the orbital socket.The plate was not the correct size and surgical procedure was extended to make adjustments to implant device.After the surgery, the patient is experiencing numbness, nerve damage, vision problems and face asymmetry.There are no plans to do a revision surgery.This report is for an unknown psi implant.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

This report is for an unknown psi implant/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

The initial complaint was reviewed and found not reportable.Upon further review it was identified that the materialise is the legal manufacturer for the complaint device and materialise has also reported this complaint to fda.

Event Description

On (b)(6), 2021, patient underwent revision due to non-united fracture through inferolateral left maxilla sinus wall.Operative reports structural injury due to compression of the infraorbital foramen.This is report 1 of 17 for (b)(4).

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.H10: additional narrative: a2, a3, a4, b5, b6, b7.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.H11: corrected data: b5, e1, b1, h1, h6: it was determined the device was a synthes device and not a materialise device.

• Brand Name: UNK - PLATES: MATRIX ORBITAL
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13284752
• MDR Text Key: 284019017
• Report Number: 2939274-2022-00209
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 81 KG