MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLATE, STRAIGHT, 4 HOLE, WITH BAR, MIDFACE; IMPLANT

Model Number	55-06704
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device evaluated by manufacturer? facility did not provide for investigation.
Event or Problem Description
It was reported that a plate had broken post-operatively, and a revision surgery was performed to re-plate the fracture.
Event or Problem Description
It was reported that a plate had broken post-operatively, and a revision surgery was performed to re-plate the fracture.
Additional Manufacturer Narrative
The postoperative plate breakage could be confirmed as the device was returned for investigation.A follow-up with the sales rep has confirmed that the surgeon has used the reported plates for condylar process fractures.The device in question is part of the mid-face fixation module and is not intended to be used for mandible fixation.The mechanical strength of the reported plate is comparably lower to that of the plates intended for mandible fixation.As shown in the related brochure (universal 2, 9410-400-184 rev.None), the minimum profile height of a plate for mandible fixation is 1.0mm, whereas the plate 55-06704 has a profile height of 0.6mm.The difference of the profile heights between the mid-face plate and mandible plate may have influenced the determined plate breakage.Stryker¿s medical expert stated that ¿this is off-label use.The mid face plates are for non-load bearing fractures; the mandible is load bearing.¿ in sum, the procedure to fixate mandible fractures with plates intended for mid-face fixation is considered as off-label use.No lot number was provided and a review of the specific manufacturing batch record and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) cannot be performed.Therefore, it is also not possible to determine the quantities released for distribution within the affected lots.Based on the investigation, there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.

• Brand Name: PLATE, STRAIGHT, 4 HOLE, WITH BAR, MIDFACE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10938338
• Report Number: 0008010177-2020-00062
• Device Sequence Number: 702627
• Product Code: JEY
• UDI-Device Identifier: 04546540365941
• UDI-Public: 04546540365941
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55-06704
• Device Catalogue Number: 55-06704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR