MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - LOCKING/SET SCREWS: SYNAPSE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking/set screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.(b)(4).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 Description

Device report from (b)(6) reports an event as follows: it was reported that an order of patient-critical parts was delayed by twenty-four (24) hours due to missing paperwork.Concomitant devices: cancellousscr synapse ø3.5 (part: 04.614.016, lot: unknown, quantity: 2).Cancellousscr synapse ø3.5 (part: 04.614.018, lot: unknown, quantity: 3).Cancellousscr synapse ø3.5 (part: 04.614.024, lot: unknown, quantity: 4).Cancellousscr synapse ø3.5 (part: 04.614.026, lot: unknown, quantity: 3).Cancellousscr synapse ø3.5 (part: 04.614.028, lot: unknown, quantity: 8).Cancellousscr synapse ø3.5 (part: 04.614.030, lot: unknown, quantity: 1).Cancellousscr synapse ø3.5 (part: 04.614.032, lot: unknown, quantity: 4).Shaft-scr synapse ø3.5 l26 tan (part: 04.614.326, lot: unknown, quantity: 2).Shaft-scr synapse ø3.5 l28 tan (part: 04.614.328, lot: unknown, quantity: 2).Shaft-scr synapse ø3.5 l30 tan (part: 04.614.330, lot: unknown, quantity: 8).Shaft-scr synapse ø3.5 l32 tan (part: 04.614.332, lot: unknown, quantity: 10).Shaft-scr synapse ø3.5 l34 tan (part: 04.614.334, lot: unknown, quantity: 2).Cancellousscr synapse ø4.5 (part: 04.614.224, lot: unknown, quantity: 4).Cancellousscr synapse ø4.5 (part: 04.614.226, lot: unknown, quantity: 4).Cancellousscr synapse ø4.5 (part: 04.614.228, lot: unknown, quantity: 2).Cancellousscr synapse ø4.5 (part: 04.614.230, lot: unknown, quantity: 4).Cancellousscr synapse ø4.5 (part: 04.614.236, lot: unknown, quantity: 4).Lockscr synapse tan (part: 04.614.508, lot: unknown, quantity: 20).Rod ø3.5 l240 ti gold (part: 498.957, lot: unknown, quantity: 3).Rod (part: unknown, lot: unknown, quantity: 1).Mono/polyaxial screw (part: unknown, lot: unknown, quantity: 1).This report is for an unknown locking/set screw.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - LOCKING/SET SCREWS: SYNAPSE
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9749931
• MDR Text Key: 189314177
• Report Number: 8030965-2020-01364
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention