MAUDE Adverse Event Report: ACUMED, LLC 50MM RIB PLATE; PLATE, FIXATION, BONE

Model Number RBL1301

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Ossification (1428); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Two (2) plates and eight (8) screws were received for evaluation.The returned parts were examined with magnification.Notes on visual appearance include: [surface condition] the plates and screws were in poor condition; this included general anodization wear, brown markings on surfaces, marking obscuration, dents/nicks on edges, marking wear/coverage, and foreign matter on surfaces or nestled within features (likely human bone).[screw thread damage] several screws had damage to locking and/or bone thread; this predominately included anodization wear with mild deformation of thread, but shearing was not present.[screw drive feature damage] several screws had damage to the lobes of the drive feature; this included physical warpage of the feature and anodization wear at the upper lobes.[plate fragmentation] both returned plates had fractured completely; the metal webbing meant to wrap around the rib had been stretched/deformed.The dual plate tabs of the rib plates had separated from the webbing completely; the plate tabs and webbing terminated at fracture planes.[plate fracture planes] plate fracture planes had varying levels of flatness but were largely flat with significant texturing.No visible ductility was present.[boney ongrowth] foreign matter had grown over one of the plate tabs as-received; this substance had grown over the surface of the tab not normally in contact with the bone/rib.It is unclear if the bone grew through the slots of the tab, around the edges of the tab, or both.It is also unclear if the noted damage to the plates and screws is relevant to the reported incident (adverse patient reaction).Additionally, it is unknown if the damage occurred during the initial implant procedure, explant procedure, or during both.No definitive conclusion on the observed phenomena can be made.

Event Description

It was reported the patient had two (2) rib plates implanted in 2019.The patient presented to another surgeon three (3) years later with pain in her ribs and requested explant of the devices.The surgeon did not know the cause of the patient's pain, but the patient has hypertrophic ossification along the original fracture site.The plates and screws were explanted on (b)(6) 2022, and it reportedly took 1.5 hours to explant the devices.This report is related to the following report numbers for the other devices (plate/screws) involved in this event: 3025141-2022-00164, 3025141-2022-00165, 3025141-2022-00166, 3025141-2022-00167, 3025141-2022-00168, 3025141-2022-00169, 3025141-2022-00170, 3025141-2022-00171, and 3025141-2022-00172.

• Brand Name: 50MM RIB PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 14595487
• MDR Text Key: 293292652
• Report Number: 3025141-2022-00163
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RBL1301
• Device Catalogue Number: RBL1301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White