WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.541 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
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Model Number SD800.541 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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.
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Event Description
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It was reported that on an unknown date, the patient developed soft tissue infection on scalp, so the surgeon had to remove the peek implant to treat the infection.At a later date when infection resides, a new peek implant will be made and implanted.Surgical delay and procedure outcome are unknown.Patient involvement was unknown.This complaint involves one (1) device.This report is for one (1) psi sd800.541 peek implant.This report is 1 of 3 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: complaint products was implanted and not available to return.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.
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Search Alerts/Recalls
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