MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNPOR TI REINFORCED FAN PLATE 0.8MM THICK-STERILE; PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Model Number	08.520.120S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: ftm, ftl.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
It was reported that on (b)(6) 2021, during the surgery a synpor titanium reinforced fan plate came apart.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.This report is for one (1) synpor ti reinforced fan plate 0.8mm thick-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: SYNPOR TI REINFORCED FAN PLATE 0.8MM THICK-STERILE
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12537565
• Report Number: 2939274-2021-05781
• Device Sequence Number: 1271354
• Product Code: GWO
• UDI-Device Identifier: 10887587026343
• UDI-Public: (01)10887587026343
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 08.520.120S
• Device Catalogue Number: 08.520.120S
• Device Lot Number: DS7005189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/27/2021
• Patient Sequence Number: 1