MAUDE Adverse Event Report: SYNTHES MEZZOVICO PSI SD800.434 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.434

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Swelling (2091); Impaired Healing (2378); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.A product development investigation has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient specific implant (psi) was removed from a male patient because the area where the device was implanted had a bad odor and had swelled.The psi was originally implanted on (b)(6) 2011.During examination it was noted that the patient had an open wound and inflamed, infected and necrotic tissues were observed.The wound was also infested with unspecified white worms.On (b)(6) 2015 the patient underwent surgery to remove the necrotic tissue and explant the psi.The surgeon did not re-insert the psi or revise the patient with another psi.The patient status as of the date of this report was noted to be stable.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a manufacturing investigation action was conducted/performed.The report indicates that the: as the problem with the according peek psi only did show up after 5 years is a strong indication, that there was a soft tissue lesion that, may be caused by the grow of the patients anatomy around the implant while the peek psi did not grow, or by another, unknown external impact, that did compromise the peek psi and it¿s integrity within the surrounding bone.These are assumptions and cannot be confirmed based on the information we do have within this complaint, but it is a reasonable explanation for the situation described in the complaint.However, based on the signed images of approval, including the statement, ¿attention, be aware that an adolescent patient will grow whereas the psi will not! appropriate follow-up is therefore essential.¿ it is likely that the surgeon did an appropriate follow-up in order to prevent such effects in adolescent patients and if he detected them, he was able to take according measures.Based on the above discussed situation and based on the fact, that additional information is missing in order to evaluate the complaint further, no further actions are taken and the complaint will be closed as indeterminate.An investigation summary was attempted.The investigation of the complaint articles has shown that: product was not returned therefore an investigation could not be performed.Additional information is missing in order to evaluate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PSI SD800.434 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5399621
• MDR Text Key: 37179748
• Report Number: 1000562954-2016-10021
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.434
• Device Lot Number: 7643648
• Other Device ID Number: (01)07611819341340(10)7643648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention