MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM; BONE SCREW, 2.7 MM X 14 MM HIGH TORQUE CROSS-DRIVE SCREW

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

The products were returned and identified on feb 20, 2017.A follow up report will be sent upon completion of the device evaluation.This is report six of six for the same event.Reports one and two through five are reported on mfr #0001032347-2016-00670 and 0001032347-2017-00158 through 0001032347-2017-00161.

Event Description

It was reported the patient had a fibula reconstruction including osteosynthesis plate with jaw condyle surgery approximately 1-2 years ago.Shortly after surgery, the lower jaw started hanging caused by the missing muscle as stabilizer on the operated side.As a result the condyle has a huge distance to the fossa and the condyle does not stay in the fossa.During the surgery to implant the custom tmj the existing recon plate with add on condyle that was not a zimmer biomet part was removed.It was identified the mandibular bone was not fused and loose at the site to be reduced.The fibula graft that was originally placed detached upon removal of the original plate.The surgeon implanted the custom mandible and fossa implants, however the mandibular head sat too far to the left about 0.5 cm, and could not be pressed into the fossa from the lateral side under strong pressure.All components (fossa and mandibula) were removed again.The implants were tested on the model, the two components on both the templates and the implants were about 1 cm apart from each other.No portable joint and implant position could be found.The operation was terminated.The fossa prosthesis was implanted as a placeholder, however the mandibular bone part was fixed with a recon plate.The surgical planning, reviewing the models, and releasing them to surgery was completed by one surgeon, however, this surgeon did not perform the surgery.The surgeon who performed the surgery was not involved in the surgical planning.The surgeon who did the surgical planning was to see the patient three months after october in order to determine if another attempt at implanting the mandible will be made.

Manufacturer Narrative

The product identity was confirmed in the evaluation.There were nine returned screws.Looking at the returned screws it can be seen that they were implanted and then removed.There are no signs of a manufacturing defect on any of the screws.The complaint is on the fit of the mandible and there are no present issues observed with the returned screws.Within the design vendor's complaint investigation report, there are indications that the skull model may have been sterilized which would change the form of the skull model and cause the implant to show the gap reported.The skull model is also fractured where the implant attaches to it.This makes it difficult to correctly position the implant on the broken skull model.The design vendor re-printed the skull model to check the implant fit on the patient anatomy and found that the implant fit the skull model.Since the planning surgeon did not conduct the surgery it is possible that the designed surgical procedure was not followed as laid out by the design vendor and the planning surgeon.The returned implant was reviewed against the product print and no discrepancies were found; the thickness was measured in multiple places with calipers and all measurements taken were within specifications.The manufactured implant matches the re-printed model sent by the design vendor.The surgeon went ahead and plated the bone graft with a reconstruction plate and requested a new tmjpm implant be designed with the patients new anatomy.The current design is no longer usable based on the interference between the implanted reconstruction plate and the tmjpm implant.This is report six of six for the same event.Reports one and two through five are reported on mfr #0001032347-2016-00670 and 0001032347-2017-00158 through 0001032347-2017-00161.

• Brand Name: LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
• Type of Device: BONE SCREW, 2.7 MM X 14 MM HIGH TORQUE CROSS-DRIVE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6380004
• MDR Text Key: 69142313
• Report Number: 0001032347-2017-00162
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK001238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 81-2714
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention